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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 defibrillation lead
PMA NumberP950022
Supplement NumberS069
Date Received04/22/2010
Decision Date01/24/2011
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 Yes
Review Memo Review Memo
Approval Order Statement 
Approval for 1) design modifications to the suture sleeve of all commercially available durata leads; 2) 7f suture sleeve accessory kit compatible with all sjm 7f leads; 3) reduction in pvp (fastpass) coating length for all dual-shock versions of commercially available durata leads; and 4) design modifications to the is-1 connector crimp connection for all trifurcated versions of the commercially- available durata leads.
Approval Order Approval Order