PERLANE L INJACTABLE GEL
FDA premarket approval P040024/S054 · decided 2011-08-18
Approval details
- PMA number
- P040024
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PERLANE L INJACTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2011-07-21
- Decision date
- 2011-08-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- NEW FILL VOLUME FOR THE DEVICE AND A NEW NEEDLE SIZE TO BE USED WITH THE NEW FILL VOLUME.
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