|
Device | KAPPA 400 DR IPG AND KAPPA 400 SR IPG |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P970012 |
Supplement Number | S058 |
Date Received | 10/08/2009 |
Decision Date | 01/21/2010 |
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 REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES. |