|
Device | OPTIMIZER Smart 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 | S027 |
Date Received | 03/13/2024 |
Decision Date | 04/12/2024 |
Product Code |
QFV |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT03970343
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval of the revised protocol (version 8) for the post-approval study (PAS) referenced above. |