SYNVISC
FDA premarket approval P940015/S015 · decided 2009-08-20
Approval details
- PMA number
- P940015
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYNVISC
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2009-04-16
- Decision date
- 2009-08-20
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.