|
Device | 350 SERIES/ENRHYTHM/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 | S247 |
Date Received | 10/25/2011 |
Decision Date | 11/23/2011 |
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 CONSOLIDATION OF MANUFACTURING OPERATIONS AND RELATED EQUIPMENT CHANGES AT A SUPPLIER¿S LOCATION. |