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 | KAPPA 400 |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P970012 |
Supplement Number | S012 |
Date Received | 11/05/2001 |
Decision Date | 12/11/2001 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS. |
|
|