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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceJEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP900061
Supplement NumberS008
Date Received10/18/1994
Decision Date08/22/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MEDTRONIC, INC., MED-REL, ROAD 909, KM. 0.4., BARRIO MARIANA, HUMACAO, PUERTO RICO, TO MANUFACTURE THE MODEL 7219D JEWEL PCD AND THE MODEL 7202D JEWEL CD
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