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 | CARDIOMESSENGER HOME MONITORING SYSTEM |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S031 |
Date Received | 02/06/2003 |
Decision Date | 02/25/2003 |
Product Codes |
DTB DXY KRG |
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 OPTIMIZED CIRCUITRY, UPGRADED MODEM, UPGRADED BATTERY, AND AESTHETIC CHANGES. |
|
|