OPTIMIZER Smart Mini Implantable Pulse Generation (IPG)
FDA premarket approval P180036/S020 · decided 2023-10-23
Approval details
- PMA number
- P180036
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPTIMIZER Smart Mini Implantable Pulse Generation (IPG)
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2023-05-01
- Decision date
- 2023-10-23
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- Approval for expanded MR Conditional labeling for the OPTIMIZER Smart Mini when combined with certain market approved pacing leads.
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