GenVisc 850

FDA Premarket Approval P140005 S004

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 genvisc 850 to help prevent any leakage of the product during administration.

DeviceGenVisc 850
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantORTHOGENRX,INC
Date Received2020-05-08
Decision Date2020-06-07
PMAP140005
SupplementS004
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 2005 South Easton Road suite 207 doylestown, PA 18901

Supplemental Filings

Supplement NumberDateSupplement Type
P140005Original Filing
S004 2020-05-08 Special (immediate Track)
S003
S002
S001

NIH GUDID Devices

Device IDPMASupp
10850653006013 P140005 000

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