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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 Nametransvenous defribilation lead system
PMA NumberP950022
Supplement NumberS001
Date Received10/15/1996
Decision Date04/23/1997
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number N
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for rv lead model rv03, svc lead models sv04 and sv05 with a solid suture sleeve, stylet models s-70-4, s-70-f, s-45-x, s-55-x and s-70-x and for use of a lser process to remove excess silicone rubber from the defibrillation coils.