OPTIMIZER Smart Mini System
FDA premarket approval P180036/S007 · decided 2021-07-30
Approval details
- PMA number
- P180036
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIMIZER Smart Mini System
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2020-09-09
- Decision date
- 2021-07-30
- Days to decision
- 324 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- Approval for commercial distribution of the OPTIMIZER SMART Mini System.
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