PMA P940015S018
- Device
- SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S018
- Product code
- MOZ
- Decision date
- 2010-11-24
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF FEDEGARI AUTOCLAVE AS AN ADDITIONAL AUTOCLAVE IN THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S018
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2010-11-24
- Decision code
- APPR
- Date received
- 2010-04-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF FEDEGARI AUTOCLAVE AS AN ADDITIONAL AUTOCLAVE IN THE MANUFACTURING PROCESS.