PMA P940015S038
- Device
- SYNVISC
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S038
- Product code
- MOZ
- Decision date
- 2017-01-18
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Reduction in the testing intervals for routine marketed product surveillance stability studies for Synvisc and Synvisc-One.
Current openFDA PMA Record#
- Device
- SYNVISC
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S038
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2017-01-18
- Decision code
- OK30
- Date received
- 2016-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in the testing intervals for routine marketed product surveillance stability studies for Synvisc and Synvisc-One.