|
Device | MEDTRONIC KAPPA 400 SERIES PACEMAKER SYSTEMS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P970012 |
Supplement Number | S018 |
Date Received | 10/06/2005 |
Decision Date | 02/16/2006 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS. |