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 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S002 |
Date Received | 06/01/1999 |
Decision Date | 09/13/1999 |
Product Codes |
DTA DTE KRG LWS |
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 device hardware and software modifications. The device, as modified, will be marketed under the trade name mycroPhylax(Plus), Phylax XM, and TMS 1000(Plus) Tachyarrhythmia Monitoring System. The devices are indicated for use in patients who are at risk of sudden death due to ventriular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmias; or recurrent poorly tolerated sustained ventricular tachycardia (VT). |
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