SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)
FDA premarket approval P940015/S018 · decided 2010-11-24
Approval details
- PMA number
- P940015
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2010-04-22
- Decision date
- 2010-11-24
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR THE INTRODUCTION OF FEDEGARI AUTOCLAVE AS AN ADDITIONAL AUTOCLAVE IN THE MANUFACTURING PROCESS.
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