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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSYNVISC, SYNVISC-ONE
Classification Nameacid, hyaluronic, intraarticular
Generic Namehylan g-f 20
ApplicantGENZYME CORP.
PMA NumberP940015
Supplement NumberS034
Date Received04/27/2015
Decision Date07/24/2015
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
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; and 6) 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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