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 | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM |
Generic Name | TESTER, PACEMAKER ELECTRODE FUNCTION |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S003 |
Date Received | 11/02/1999 |
Decision Date | 05/01/2000 |
Product Codes |
DTA DTE KRG LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for: 1) the introduction of Patient data Manager Softward, PDM 2000, and 2) a new method for determining the Use Before Date of Biotronik's ICDs. |
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