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. |
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Device | KAPPA 400 |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P970012 |
Supplement Number | S079 |
Date Received | 11/15/2010 |
Decision Date | 12/13/2010 |
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 THE MOLDS USED IN THE MANUFACTURE OF THE DEVICES AND THE ADDITION OF A SECOND SUPPLIER OF THESE MOLDS. |
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