PMA P940015S005
- Device
- SYNVISC (HYLAN G-F 20)
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S005
- Product code
- MOZ
- Decision date
- 2000-09-12
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL FOR A LABELING CHANGE EXTENDING THE TIME OF TREATMENT EFFECT TO 26 WEEKS.
Current openFDA PMA Record#
- Device
- SYNVISC (HYLAN G-F 20)
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S005
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2000-09-12
- Decision code
- APPR
- Date received
- 2000-03-31
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A LABELING CHANGE EXTENDING THE TIME OF TREATMENT EFFECT TO 26 WEEKS.