|
Device | Optimizer Smart System (IPG) |
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 | S001 |
Date Received | 04/26/2019 |
Decision Date | 05/21/2019 |
Product Code |
QFV |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updated labeling reflecting the increase in projected battery longevity of the OPTIMIZER SMART IPG. |