|
Device | KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG |
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 | S130 |
Date Received | 02/18/2009 |
Decision Date | 08/05/2009 |
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 CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING. |