|
Device | ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA 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 | S225 |
Date Received | 05/10/2011 |
Decision Date | 06/09/2011 |
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 AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM. |