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. |
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Device | SJM CRTDS |
Generic Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
Applicant |
St. Jude Medical |
15900 valley view ct. |
sylmar, CA 91342-3577 |
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PMA Number | P030054 |
Supplement Number | S212 |
Date Received | 12/23/2011 |
Decision Date | 05/10/2012 |
Product Code |
NIK
|
Advisory Committee |
Cardiovascular |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERATIONS MALAYSIA (SJM-MYPE) IN PENANG, MALAYSIA. |
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