PMA P940015S029
- Device
- SYNVISC AND SYNVISC ONE
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S029
- Product code
- MOZ
- Decision date
- 2014-08-06
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL FOR CHANGES TO THE QUALITY CONTROL TEST METHODS.
Current openFDA PMA Record#
- Device
- SYNVISC AND SYNVISC ONE
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S029
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2014-08-06
- Decision code
- APPR
- Date received
- 2013-09-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE QUALITY CONTROL TEST METHODS.