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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.
 
DevicePROMOTE, PROMOTE+, PROMOTE ACCEL AND UNIFY CRT-D'S AND LEADS AND MERLIN PROGRAMMER
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP030054
Supplement NumberS148
Date Received04/30/2010
Decision Date06/22/2010
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A LABELING CHANGE FROM SJ-4 TO DF-4 FOR ST. JUDE MEDICAL HIGH VOLTAGE LEAD, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRODUCTS.
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