RESTYLANE
FDA premarket approval P020023/S008 · decided 2004-07-23
Approval details
- PMA number
- P020023
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RESTYLANE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2004-06-22
- Decision date
- 2004-07-23
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR THE PRODUCT BOX LABEL TO SAY "SYRINGE CONTENTS ARE STERILE".
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