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Device | ADVISA SR MRI A3SR01; IMPLANTABLE PULSE GENERATOR, DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR, SOFTWARE MODEL 9995 |
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 | S374 |
Date Received | 04/23/2014 |
Decision Date | 03/19/2015 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADVISA SR MRI A3SR01 IMPLANTABLE PULSE GENERATOR IN COMBINATION WITH THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI TO BE MARKETED AS THE ADVISA SR MRI SURESCAN. IN ADDITION YOU REQUESTED APPROVAL FOR MODIFICATIONS TO THE ADVISA SR MRI AND ADVISA DR MRI SOFTWARE APPLICATION MODEL 9995. |