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 | BELOS VR 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 | S004 |
Date Received | 04/27/2001 |
Decision Date | 07/12/2001 |
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 A NEW ICD SYSTEM THAT INCLUDES THE FOLLOWING: BELOS VR ICD (MODEL 330 444), BELOS TEST HOUSING (MODEL 331 116), AND BELOS VR PHYLAX XM/MYCROPHYLAX/PHYLAX 06/TMS 1000 APPLICATION SOFTWARE 1-K01.0.A (MODEL 338 045). THE DEVICE, AS MODIFIED IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. |
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