Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | OPTIMIZER Smart Mini 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 | S025 |
Date Received | 12/04/2023 |
Decision Date | 02/09/2024 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement approval for implantable pulse generator firmware version 1.11 to update the charging algorithm and bug fixes. |
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