OPTIMIZER Smart, OPTIMIZER Smart Mini, OPTIMIZER Lite
FDA premarket approval P180036/S033 · decided 2025-03-27
Approval details
- PMA number
- P180036
- Supplement
- S033
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPTIMIZER Smart, OPTIMIZER Smart Mini, OPTIMIZER Lite
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2024-08-12
- Decision date
- 2025-03-27
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- additional of a raw material supplier for epoxy resin used in the OPTIMIZER IPG devices.
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