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The IS4/DF4 plug can be indicated for a patient with an implantable pacemaker/defibrillator that has an unused IS4/DF4 receptacle. The plug prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle.

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The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard. The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard. The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard. The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard. The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings. The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.

The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard. The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard. The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard. The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard. The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings. The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.

1) Model 6017: It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals. 2) Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal. 3) Model 6020: It is a single barrel adapter that is designed to join CPI unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.

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Pacing bipolar lead adaptors are indicated for connecting the existing pacing lead(s) to a compatible pacemaker header cavity.

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Pacing Lead Adaptors/Extensions, unipolar/bipolar are indicated for connecting the pacing lead(s) to a compatible pacemaker header cavity.

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The Model 2872 Lead Adaptor Kit is designed to connect two pacing leads with bipolar connectors (IS-1 Bl)* to a pulse generator featuring a bipolar connector block which meets the IS-1 Bl* standard. *IS-1 refers to an International Connector Standard (ISO 5841-3; 1992) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

The Model 2872 lead adaptor consists of stainless steel connectors, MP35N conductor coils, and silicone rubber insulation. Also packaged in the kit are wrench / setscrew assemblies, and a tube of medical grade adhesive.

Lead adapters, including silicone adapter sleeves, when used in conjunction with their accessories, provide a means of securely connecting pace/sense leads with otherwise mechanically incompatible pacemaker devices.

BIOTRONIK A1 Series Lead Adapters and the PEH Adapter Sleeve are designed to be chronically implantable, safe and effective through design functionality, simplicity and material biocompatibility. Both devices were cleared for distribution pursuant to FDA review of the 1990 510(k). For A 1 Series Lead Adapters, the following changes are proposed: - a titanium alloy (Ti4) will be used for the manufacture of the device set screw; ● - . the silicone of the lead connector receptacles and connectors will change from DOW Corning HTV silicones to Silopren LSR-4070; - NuSil MED 1137 will be used as a silicone tube adhesive; . - slight design improvements and modifications related to the above described silicone . material changes; - blister packaging material will change from XT Polymer to PETG; . - the catalog number will change. . For the PEH Adapter Sleeve, the following changes are proposed: - the main silicone-based MOC will change from DOW Corning HTV silicones to . Silopren LSR-4070; - . the catalog number will change. The following devices were submitted within the 1990 510(k): | A1-A: | adapts one 5 mm unipolar connector to fit IS-1 connector receptacle | |---------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | A1-B: | adapts one 6 mm unipolar connector to fit IS-1 connector receptacle | | A1-ABP: | adapts two 5 mm unipolar connectors to fit IS-1 connector receptacle | | A1-MBP: | adapts one 3.2 mm "in line" bipolar connector to fit IS-1 connector receptacle; or, adapts one 3.2 mm unipolar connector to fit IS-1 connector receptacle. | | A1-Z: | adapts one unipolar connector without a connector to fit IS-1 connector receptacle | | A6-A: | adapts one unipolar connector without a connector to fit 5 mm unipolar connector receptacle | | A6-B: | adapts one unipolar connector without a connector to fit 6 mm unipolar connector receptacle | PEH Sleeve: adapts one unipolar lead with 5 mm connector to fit 6 mm connector receptacle.