PMA P940015S015
- Device
- SYNVISC
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S015
- Product code
- MOZ
- Decision date
- 2009-08-20
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE PRODUCT LEAFLET/PACKAGE INSERT FOR SYNVISC TO MAINTAIN CONSISTENCY WITH WORDING PREVIOUSLY APPROVED FOR SYNVISC-ONE PACKAGE INSERTS.
Current openFDA PMA Record#
- Device
- SYNVISC
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S015
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2009-08-20
- Decision code
- APPR
- Date received
- 2009-04-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE PRODUCT LEAFLET/PACKAGE INSERT FOR SYNVISC TO MAINTAIN CONSISTENCY WITH WORDING PREVIOUSLY APPROVED FOR SYNVISC-ONE PACKAGE INSERTS.