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510(k) Data Aggregation
K Number
K022222Device Name
LAMITRODE S-SERIES (S4 AND S8) LEADS
Manufacturer
Date Cleared
2002-08-08
(30 days)
Product Code
Regulation Number
882.5880Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED NEUROMODULATION SYSTEM,INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ANS Lamitrode S-Series (S4 and S8) Leads, models 3243, 3246, 3283 and 3286, are indicated for the treatment of chronic pain of the trunk and limbs. either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Lamitrode S4 and S8 leads are design to be connected to ANS neurostimulation receiver, Models 3408 and 3416, transmitter models 3508 and 3516 and extension models 3341, 3342, 3343, 3346, 3382, 3383 and 3386.
Device Description
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