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 DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S033 |
Date Received | 06/24/2003 |
Decision Date | 12/17/2003 |
Product Codes |
DTB DXY KRG |
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 MODIFICATIONS TO HOME MONITORING THAT WILL ALLOW PHYSICIANS TO RECEIVE THE IMPLANT DATA VIA THE INTERNET, EMAIL, FAX OR MOBILE PHONE. HOME MONITORING MAY BE USED WITH THE FOLLOWING BIOTRONIK DEVICES: PHILOS DR-T, BELOS DR-T, BELOS VR-T, AND CARDIAC AIRBAG-T. |
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