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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namesubcutaneous, unipolar, cardioversion/defibrillation lead
PMA NumberP920015
Supplement NumberS021
Date Received02/05/2001
Decision Date06/11/2001
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 6996 sq lead system and the 6996t tunneling tool. The model 6996 sq lead system is for single, long-term subcutaneous use and is intended for use in patients in which implantable cardioverter defibrillators (icd) are indicated. The lead is intended for use if a standard icd system with one or two transvenous leads has not been efficacious in providing acceptable dft measurements. The model 6996 sq lead is intended for use only with the following systems: a medtronic icd featuring a connector block with at least two df-1 connector ports; and a medtronic right ventricular lead for defibrillating/pacing/sensing. In addition, a third defibrillation lead, such as any medtronic svc lead, may be used with a lead adaptor.