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 | KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18 |
Generic Name | TESTER, PACEMAKER ELECTRODE FUNCTION |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S013 |
Date Received | 02/19/2003 |
Decision Date | 07/29/2003 |
Product Codes |
DTA DTE KRG LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE. |
|
|