SYNVISC, SYNVISC-ONE
FDA premarket approval P940015/S034 · decided 2015-07-24
Approval details
- PMA number
- P940015
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNVISC, SYNVISC-ONE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2015-04-24
- Decision date
- 2015-07-24
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES FOR THE DELIVERY SYRINGES FOR SYNVISC® AND SYNVISC-ONE®:1) CHANGE OF THE CLEAR PLASTIC RIGID TIP CAP (PRTC) TO A BLUE PRTC;2) CHANGE OF THE CLEAR POLYSTYRENE PLUNGER ROD, WITH DIAMETERS OF 8.0 MM AND 13.4 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A BLUE POLYPROPYLENE PLUNGER ROD WITH DIAMETERS OF 8.2 MM AND 13.7 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 3) CHANGE OF THE THUMB PRESS ON THE PLUNGER ROD FROM A FLAT, SMOOTH SU
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