PMA P940015S021
- Device
- SYNVISC AND SYNVISC-ONE
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S021
- Product code
- MOZ
- Decision date
- 2011-07-07
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- REPLACEMENT OF A POLYETHYLENE CYLINDRICAL TANK WITH A STAINLESS STEEL ROTATING BLENDER SYSTEM.
Current openFDA PMA Record#
- Device
- SYNVISC AND SYNVISC-ONE
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S021
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2011-07-07
- Decision code
- OK30
- Date received
- 2011-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACEMENT OF A POLYETHYLENE CYLINDRICAL TANK WITH A STAINLESS STEEL ROTATING BLENDER SYSTEM.