|
Device | Optimizer Smart System and 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 | S008 |
Date Received | 06/24/2021 |
Decision Date | 10/06/2021 |
Product Code |
QFV |
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 for removing the Indications For Use requirement for patients to be in normal sinus rhythm. |