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 | 3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03 |
Generic Name | Programmer, pacemaker |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S063 |
Date Received | 07/02/1999 |
Decision Date | 07/21/1999 |
Product Codes |
DXY KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the Model 3303 V1.03 programmer software for use with the Models 3500/3510 Programmers. |
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