GELSYN-3

FDA Premarket Approval P110005 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 inclusion of the routine use of bioindicators to monitor efficacy of the sterilization cycle for every batch of gelsyn-3.

DeviceGELSYN-3
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantIBSA INSTITUT BIOCHIMIQUE SA
Date Received2020-06-29
Decision Date2020-07-10
PMAP110005
SupplementS004
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement TypeSpecial (immediate Track)
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
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

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