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 | AUTIMA PACING SYSTEM (META DDD MODEL 1230) |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P820018 |
Supplement Number | S046 |
Date Received | 09/12/1990 |
Decision Date | 10/15/1990 |
Withdrawal Date
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06/20/2007 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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