PMA P940015S013
- Device
- SYNVISC
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S013
- Product code
- MOZ
- Decision date
- 2009-04-10
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL FOR THE RELOCATION OF MANUFACTURING PROCESSES WITHIN THE SAME FACILITY AND THE ADDITION OF AN ALTERNATE SYRINGE FILLING MACHINE.
Current openFDA PMA Record#
- Device
- SYNVISC
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S013
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2009-04-10
- Decision code
- APPR
- Date received
- 2008-09-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE RELOCATION OF MANUFACTURING PROCESSES WITHIN THE SAME FACILITY AND THE ADDITION OF AN ALTERNATE SYRINGE FILLING MACHINE.