GELSYN-3

FDA Premarket Approval P110005 S005

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

A change to the bacterial endotoxins (be) test method used for the device components

DeviceGELSYN-3
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantIBSA INSTITUT BIOCHIMIQUE SA
Date Received2020-09-04
Decision Date2020-10-08
PMAP110005
SupplementS005
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address IBSA INSTITUT BIOCHIMIQUE SA via Al Ponte 13, Ch-6903 lugano Ticino 6903

Supplemental Filings

Supplement NumberDateSupplement Type
P110005Original Filing
S006 2020-09-04 30-day Notice
S005 2020-09-04 30-day Notice
S004 2020-06-29 Special (immediate Track)
S003 2018-04-09 Special (immediate Track)
S002 2017-01-19 Normal 180 Day Track
S001 2016-03-25 Real-time Process

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.