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 | EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI; |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S144 |
Date Received | 10/31/2014 |
Decision Date | 11/21/2014 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES TO EQUIPMENT USED IN THE PRODUCTION OF IS-1 CONNECTOR PORTS. |
|
|