PMA P940015S035
- Device
- SYNVISC
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S035
- Product code
- MOZ
- Decision date
- 2015-05-26
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- ADDITION OF A FILTRATION STEP IN THE MANUFACTURING PROCESS FOR SYNVISC/SYNVISC-ONE (HYLAN G-F20).
Current openFDA PMA Record#
- Device
- SYNVISC
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S035
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2015-05-26
- Decision code
- OK30
- Date received
- 2015-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A FILTRATION STEP IN THE MANUFACTURING PROCESS FOR SYNVISC/SYNVISC-ONE (HYLAN G-F20).