RESTYLANE / RESTYLANE-L, PERLANE, PERLANE-L(INJECTABLE GELS), RESTYLANE SILK
FDA premarket approval P040024/S078 · decided 2014-11-21
Approval details
- PMA number
- P040024
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE / RESTYLANE-L, PERLANE, PERLANE-L(INJECTABLE GELS), RESTYLANE SILK
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2014-10-03
- Decision date
- 2014-11-21
- Days to decision
- 49 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- EXPANSION OF CLEANROOM F1 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.