PMA P940015S006
- Device
- SYNVISC HYLAN G-F 20
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S006
- Product code
- MOZ
- Decision date
- 2003-09-26
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL FOR LABELING CHANGES INCLUDING REMOVAL OF A PRECAUTION REGARDING REPEAT COURSES OF INJECTION, AND ADDING INFORMATION ABOUT ADVERSE EVENTS.
Current openFDA PMA Record#
- Device
- SYNVISC HYLAN G-F 20
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S006
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2003-09-26
- Decision code
- APPR
- Date received
- 2002-03-19
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES INCLUDING REMOVAL OF A PRECAUTION REGARDING REPEAT COURSES OF INJECTION, AND ADDING INFORMATION ABOUT ADVERSE EVENTS.