SYNVISC HYLAN G-F 20
FDA premarket approval P940015/S010 · decided 2003-09-12
Approval details
- PMA number
- P940015
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYNVISC HYLAN G-F 20
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2003-08-15
- Decision date
- 2003-09-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR CHANGES TO THE PATIENT PACKAGE INSERT FOR SYNVISC THAT ARE INTENDED TO STRENGTHEN THE INFORMATION FOR PATIENTS BY INCREASING THE TYPE SIZE, DECREASING THE READING LEVEL, MORE FULLY DESCRIBING THE U.S. CLINICAL TRIAL, DESCRIBING THE SIGNS OF AN ALLERGIC REACTION, AND BY MAKING OTHER REVISIONS TO THE INSERT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.