| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | SYNVISC, SYNVISC-ONE |
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| Generic Name | Acid, hyaluronic, intraarticular |
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| Applicant | Sanofi GENZYME CORP.
450 Water St.
Cambridge, MA 02141 |
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| PMA Number | P940015 |
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| Supplement Number | S034 |
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| Date Received | 04/24/2015 |
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| Decision Date | 07/24/2015 |
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| Product Code |
MOZ |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order 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 SURFACE WITH DIAMETERS OF 12.7 MM AND 18.6 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A FLAT, TEXTURED SURFACE WITH DIAMETERS OF 19 MM AND 26.7 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 4) CHANGE OF THE GREY PROPYLENE OVAL-SHAPED FINGER FLANGE, WITH OVERALL WIDTHS OF 28.4 MM AND 43.8 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A BLUE PROPYLENE WING-SHAPED FINGER FLANGE, WITH OVERALL WIDTHS OF 35.6 MM AND 43.9 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 5) CHANGE OF THE TRANSPARENT SYRINGE LABEL TO A TRANSLUCENT SYRINGE LABEL WITH GRADED BLUE COLOR; AND6) CHANGE OF THE SYNVISC-ONE® BLISTER TRAY TO INCORPORATE A FINGER FLANGE CAVITY MODIFIED TO ACCOMMODATE THE NEW FLANGE DESIGN.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNVISC® AND SYNVISC-ONE® AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G. ACETAMINOPHEN. |
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