|
Device | KAPPA 600/700/650/800/900/RELIA/ENPULSE/ADAPTA/VERSA/SENSIA IPGS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S175 |
Date Received | 06/25/2010 |
Decision Date | 07/23/2010 |
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 ADDITION OF A NEW PIECE OF EQUIPMENT USED IN THE BATTERY BURN-IN PROCESS. |