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 | AV PLUS DX, MODEL 1368 |
Generic Name | Programmer, pacemaker |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S090 |
Date Received | 12/04/2002 |
Decision Date | 01/22/2003 |
Product Codes |
DTB DXY KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS. |
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