SYNVISC
FDA premarket approval P940015/S008 · decided 2003-07-09
Approval details
- PMA number
- P940015
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYNVISC
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2003-01-15
- Decision date
- 2003-07-09
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR AN EXTENSION OF THE SHELF LIFE OF SYNVISC TO 36 MONTHS AT 30 DEGREES C.
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