SYNVISC, SYNVISC-ONE
FDA premarket approval P940015/S033 · decided 2014-08-21
Approval details
- PMA number
- P940015
- Supplement
- S033
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYNVISC, SYNVISC-ONE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2014-07-09
- Decision date
- 2014-08-21
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR THE UPDATING OF THE PACKAGE INSERT AND PATIENT INFORMATION LEAFLET WITH RESPECT TO ADVERSE EVENT INFORMATION ON PSEUDOSEPSIS, ALLERGIC REACTIONS, AND HYPERSENSITIVITY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.