|
Device | SIGMA/MEDTRONIC 350 SERIES/ENRHYTHM IPG/ADAPTA/SENSIA/RELIA/VERSA |
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 | S160 |
Date Received | 02/19/2010 |
Decision Date | 07/16/2010 |
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 AUTOMATION OF DIMENSIONAL TESTING. |