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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 NameSUPARTZ
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantSEIKAGAKU CORP.
PMA NumberP980044
Supplement NumberS007
Date Received07/21/2008
Decision Date07/07/2009
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Physical Medicine
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the manufacturing process: 1) replacement of wfi manufacturing equipment; 2) addition of a sensor for preventing double capping; 3) replacement of the multiplexer processor; 4) addition of a syringe label sensor; 5) replacement of the electronic balance; 6) change of knockers used to push rubber pistons into glass syringes during the filling media fill test (mft); 7) addition of a second filtration tank in order to facilitate the manufacturing of plastic and glass syringe products on consecutive days; and 8) installation of a new storage room for raw material. The device, as modified, will be marketed under the trade name supartz® and is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e. G. , acetaminophen.
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