Gel-Syn™

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P110005 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 the addition of a needle to the gel-syn packaging configuration

DeviceGel-Syn™
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantIBSA INSTITUT BIOCHIMIQUE SA
Date Received2016-03-25
Decision Date2016-05-23
PMAP110005
SupplementS001
Product CodeMOZ
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
S009 2021-03-31 135 Review Track For 30-day Notice
S008 2021-03-03 30-day Notice
S007 2020-12-03 30-day Notice
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

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