BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY

Aid, Surgical, Viscoelastic

FDA Premarket Approval P960011 S010

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 to include ioltech, cidra, puerto rico as a distributor for biolon in the united states.

DeviceBIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
Classification NameAid, Surgical, Viscoelastic
Generic NameAid, Surgical, Viscoelastic
ApplicantAmring Pharmaceuticals
Date Received2005-05-11
Decision Date2005-09-15
PMAP960011
SupplementS010
Product CodeLZP
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Amring Pharmaceuticals 1235 Westlakes Drive suite 205 berwyn, PA 19312

Supplemental Filings

Supplement NumberDateSupplement Type
P960011Original Filing
S034 2022-09-08 30-day Notice
S033
S032 2019-05-07 Real-time Process
S031 2019-04-04 30-day Notice
S030 2018-03-30 30-day Notice
S029 2018-02-12 Special (immediate Track)
S028 2017-12-07 30-day Notice
S027 2017-12-06 30-day Notice
S026 2014-07-15 30-day Notice
S025 2014-04-28 30-day Notice
S024 2013-11-13 30-day Notice
S023 2013-05-08 30-day Notice
S022 2013-01-15 30-day Notice
S021 2012-03-05 30-day Notice
S020 2011-12-29 30-day Notice
S019 2011-03-02 30-day Notice
S018 2011-02-10 Special (immediate Track)
S017 2009-12-18 135 Review Track For 30-day Notice
S016 2009-12-07 30-day Notice
S015 2009-12-07 30-day Notice
S014 2009-11-09 30-day Notice
S013 2008-01-15 30-day Notice
S012 2006-11-01 Normal 180 Day Track No User Fee
S011 2006-09-18 Real-time Process
S010 2005-05-11 Normal 180 Day Track No User Fee
S009 2004-07-09 Normal 180 Day Track
S008 2002-03-18 Normal 180 Day Track
S007 2001-08-08 Normal 180 Day Track
S006 2000-09-27 135 Review Track For 30-day Notice
S005 2000-04-25 30-day Notice
S004 2000-04-11 Normal 180 Day Track
S003 1999-08-03 30-day Notice
S002 1999-03-29 Normal 180 Day Track
S001 1998-08-31 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15060156070380 P960011 001
01369918000007 P960011 027

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