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 | PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE. |
Generic Name | permanent pacemaker Electrode |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S015 |
Date Received | 08/07/2000 |
Decision Date | 09/05/2000 |
Product Codes |
DTB DXY |
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 THE ACTIVATION OF THE PMT MANAGEMENT AND AV DELAY FEATURES IN THE PHILOS PULSE GENERATOR FAMILY, MODIFICATIONS TO THE PROGRAMMER SOFTWARE RESULTING IN VERSION B-K01.0.U, THE PGH 3000 PROGRAMMER HEAD, AND THE VK-92 PROGRAMMER PRINTER CABLE. |
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