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 | AFFINITY SR/DR |
Generic Name | Programmer, pacemaker |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S062 |
Date Received | 05/25/1999 |
Decision Date | 06/21/1999 |
Product Codes |
DXY KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement The 30-Day Notice requested elimination of redundant testing in the Affinity pulse generator manufacturing process. |
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