PERLANE
FDA premarket approval P040024/S108 · decided 2019-07-31
Approval details
- PMA number
- P040024
- Supplement
- S108
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERLANE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2019-01-31
- Decision date
- 2019-07-31
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for revisions to the clinician and patient labeling of Perlane to include updated safety information based upon post marketing surveillance data.
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