RESTYLANE, PERLANE, RESTYLANE L, PERLANE L, RESTYLANE SILK INJECTABLE GELS
FDA premarket approval P040024/S076 · decided 2014-12-08
Approval details
- PMA number
- P040024
- Supplement
- S076
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE, PERLANE, RESTYLANE L, PERLANE L, RESTYLANE SILK INJECTABLE GELS
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2014-07-02
- Decision date
- 2014-12-08
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR THE PROPOSED INTRODUCTION OF AN ALTERNATE BULK MANUFACTURING ROOMIN THE MANUFACTURING PROCESS USED IN FACTORY 2 (F2) AT THE QMED FACILITY IN UPPSALA, SWEDEN.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.