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510(k) Data Aggregation
K Number
K091206Device Name
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
Manufacturer
Date Cleared
2009-05-18
(24 days)
Product Code
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
TRANSOMA MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sleuth AT system is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- . Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac . arrhythmia
Device Description
The Sleuth AT Implantable Cardiac System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth AT Implantable Cardiac System comprises three interrelated components: Implantable Loop Recorder (ILR), Personnel Diagnostic Manager (PDM) and Base Station,
The PDM software was updated from Version 4.2 to Version 4.3. The Version 4.3 software incorporates a Service Menu in the PDM and minor software bug fixes. The Service Menu includes time zone set-up, data review option and transfer log. No other changes to the system were made.
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K Number
K083828Device Name
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT
Manufacturer
Date Cleared
2009-02-11
(50 days)
Product Code
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
TRANSOMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sleuth AT system is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- Patients with clinical syndromes or situations at increased risk of cardiac . arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac . arrhythmia
Device Description
The Sleuth AT Implantable Cardiac System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth AT Implantable Cardiac System comprises three interrelated components: Implantable Loop Recorder (ILR), Personnel Diagnostic Manager (PDM) and Base Station.
The Sleuth AT System incorporates modified brady, asystole, and tachy detection algorithms; additional trending capabilities; EMG detection/rejection; and program pending mode when compared to the original Sleuth System. There are no changes to the Indications for Use and only minor mechanical updates to the ILR and PDM.
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K Number
K073147Device Name
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
Manufacturer
Date Cleared
2007-12-03
(25 days)
Product Code
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
TRANSOMA MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- Patients with clinical syndromes or situations at increased risk of cardiac . arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac . arrhythmia
Device Description
The Sleuth Implantable ECG System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth Implantable ECG System comprises three interrelated components: Implantable Monitoring Device (IMD), Activator and Base Station.
The modification described in this Special 510(k) is the addition of an 8 cm Antenna Accessory Kit option (Model 3000-08) for use with the IMD, Model 2010.
The 8 cm antenna gives the physician an additional option. The Accessory Kit contains an 8 cm antenna and torque wrench. No changes have been made to the torque wrench.
The only difference between the original 6 cm antenna and the 8 cm antenna is the length. The antenna measures 8 cm from the IS-1 connector to tip.
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