RHA 2, RHA 3, and RHA 4 dermal fillers
FDA premarket approval P170002/S002 · decided 2019-03-22
Approval details
- PMA number
- P170002
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RHA 2, RHA 3, and RHA 4 dermal fillers
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2019-02-21
- Decision date
- 2019-03-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Automation of the degassing process.
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