|
Device | OPTIMIZER Smart Mini System |
Generic Name | Implantable pulse generator |
Applicant | Impulse Dynamics (USA), Inc. 50 Lake Center Executive Parkway 401 Route 73N, Bldg. 50 ste 100 Marlton, NJ 08053 |
PMA Number | P180036 |
Supplement Number | S012 |
Date Received | 12/23/2021 |
Decision Date | 11/14/2022 |
Product Code |
QFV |
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 OPTIhome Remote Patient Monitoring System and Patient App for use as accessories to the OPTIMIZER Smart Mini System. |