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. |
|
Device | BELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S005 |
Date Received | 09/25/2002 |
Decision Date | 12/20/2002 |
Product Code |
MRM |
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 1) NEW ADDITIONAL PULSE GENERATORS TO THE BELOS FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND 2) MODIFICATIONS TO THE LEGALLY MARKETED BELOS VR/VR-T ICD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BELOS DR, DR-T, VR, VR-T ICD SYSTEMS AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYMIAS. |
|
|