CyPass Stent

FDA Premarket Approval P150037 S003

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

Additional controlled environment room (cer) at the approved cypass manufacturing facility.

DeviceCyPass Stent
Generic NameIntraocular Pressure Lowering Implant
ApplicantAlcon Research, Ltd
Date Received2016-11-03
Decision Date2016-11-17
PMAP150037
SupplementS003
Product CodeOGO 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Alcon Research, Ltd 6201 South Freeway fort Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P150037Original Filing
S014 2019-12-20 Normal 180 Day Track No User Fee
S013
S012
S011 2018-07-16 30-day Notice
S010 2018-06-25 30-day Notice
S009 2018-05-04 30-day Notice
S008 2017-09-25 Normal 180 Day Track
S007 2017-07-27 Normal 180 Day Track No User Fee
S006 2017-06-02 Normal 180 Day Track No User Fee
S005 2017-04-20 30-day Notice
S004 2017-03-15 30-day Notice
S003 2016-11-03 30-day Notice
S002 2016-08-26 Normal 180 Day Track No User Fee
S001 2016-08-24 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00380657540075 P150037 008

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.