RESTYLANE INJECTABLE GELS
FDA premarket approval P040024/S035 · decided 2009-03-05
Approval details
- PMA number
- P040024
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE INJECTABLE GELS
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2009-02-09
- Decision date
- 2009-03-05
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- CHANGES AS FOLLOWS: 1) ADD A NEW RAW MATERIAL SUPPLIER; 2) CHANGE THE SITE FOR RAW MATERIAL QUALITY ASSURANCE TESTING TO Q-MED AB; 3) ADD A HEAVY METALS TEST FOR RAW MATERIALS; AND 4) MODIFY A TEST METHOD FOR THE QUALITY CONTROL OF THE FINISHED PRODUCT.
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