Premarket Approval (PMA)

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 Name: SUPARTZ
• Classification Name: acid, hyaluronic, intraarticular
• Generic Name: sodium hyaluronate
• Applicant: SEIKAGAKU CORP.
• PMA Number: P980044
• Supplement Number: S007
• Date Received: 07/21/2008
• Decision Date: 07/07/2009
• Product Code: MOZ [ Registered Establishments with MOZ ]
• Advisory Committee: Physical Medicine
• Supplement Type: 135 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.