SYNVISC & SYNVISC-ONE (HYLAN G-F 20)
FDA premarket approval P940015/S014 · decided 2009-03-11
Approval details
- PMA number
- P940015
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNVISC & SYNVISC-ONE (HYLAN G-F 20)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2009-02-17
- Decision date
- 2009-03-11
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- REMOVAL OF THE CYTOTOXICITY TEST (USP<87> BIOLOGICAL REACTIVITY TEST, IN VITRO) FROM THE HYLAN B-10 GEL IN-PROCESS SPECIFICATION FOR THE DEVICE.
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