|
Device | Advisa MRI DR /SR SureScan Implantable Pulse Generators (IPGs) |
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 | S481 |
Date Received | 11/02/2016 |
Decision Date | 04/25/2017 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of 1.5 and 3T MR Conditional Labeling for SelectSecure MRI SureScan Lead Model 3830. |