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 | ACTROS, AXIOS, CYLOC, DROMOS, ERGOS, GEMNOS, KAIROS, KALOS, NANOS, NEOS, PHILOS, PHILOS II, PIKOS, PROTOS, TRIOS, BA03.. |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S043 |
Date Received | 02/24/2006 |
Decision Date | 04/24/2006 |
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 THE ICS 3000 WITH IMPLANT MODULE. |
|
|