|
Device | 350 SERIES/ADAPTA/ENPULSE/KAPPA 600/650/700/800/900/SIGMA |
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 | S195 |
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. |