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 AND CYLOS DR-T |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S050 |
Date Received | 01/22/2007 |
Decision Date | 02/13/2007 |
Product Code |
NVZ |
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 MODIFICATIONS TO THE CARDIOMESSENGER AND CARDIOMESSENGER II USED WITH THE REFERENCED DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES: CARDIOMESSENGER TLINE AND CARDIOMESSENGER II LLT AND ARE INDICATED FOR TRANSMITTING DIAGNOSTIC PATIENT DATA FROM THE DEVICE TO THE PHYSICIAN. |
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