OPTIMIZER Smart System
FDA premarket approval P180036/S014 · decided 2022-09-06
Approval details
- PMA number
- P180036
- Supplement
- S014
- 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
- 2022-07-08
- Decision date
- 2022-09-06
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- Approval for revision to exclusion criteria in the Optimizer SMART PAS protocol.
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