OPTIMIZER Smart System
FDA premarket approval P180036/S035 · decided 2024-10-23
Approval details
- PMA number
- P180036
- Supplement
- S035
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- OPTIMIZER Smart System
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2024-09-25
- Decision date
- 2024-10-23
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180036.
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