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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.
 
Trade NameBIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namebipolar endocardial leads
ApplicantGUIDANT CORP.
PMA NumberP830060
Supplement NumberS042
Date Received10/16/1996
Decision Date11/12/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate sterilization facility located at cosmed of illinois, 1160 northpoint blvd. , waukegan, il 60085 - this supplement was review under the pilot program described in 4/20/96 dear ceo ltr - this approval applies only to the sterilization site -.
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