PMA P940015S014
- Device
- SYNVISC & SYNVISC-ONE (HYLAN G-F 20)
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S014
- Product code
- MOZ
- Decision date
- 2009-03-11
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- REMOVAL OF THE CYTOTOXICITY TEST (USP<87> BIOLOGICAL REACTIVITY TEST, IN VITRO) FROM THE HYLAN B-10 GEL IN-PROCESS SPECIFICATION FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- SYNVISC & SYNVISC-ONE (HYLAN G-F 20)
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S014
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2009-03-11
- Decision code
- OK30
- Date received
- 2009-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF THE CYTOTOXICITY TEST (USP BIOLOGICAL REACTIVITY TEST, IN VITRO) FROM THE HYLAN B-10 GEL IN-PROCESS SPECIFICATION FOR THE DEVICE.