TriVisc

FDA Premarket Approval P160057 S001

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.

Pre-market Approval Supplement Details

Approval for revision of the instructions for administration of trivisc to help prevent any leakage of the product during administration.

DeviceTriVisc
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantORTHOGENRX,INC
Date Received2020-05-08
Decision Date2020-06-07
PMAP160057
SupplementS001
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ORTHOGENRX,INC 3805 Old Easton Road doylestown, PA 18902-8400

Supplemental Filings

Supplement NumberDateSupplement Type
P160057Original Filing
S001 2020-05-08 Special (immediate Track)

NIH GUDID Devices

Device IDPMASupp
10850653006044 P160057 000

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