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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 NameENDOTAK SQUARE ARRAY XP SUBCUTANEOUS LEAD, SQUARE PATCH LEAD, EPICARDIAL PATCHES
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameprogrammer recorder monitor (prm) for implantable pulse generators
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS033
Date Received08/21/2000
Decision Date09/25/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at guidant puerto rico, dorado, puerto rico.
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