Preveleak Surgical Sealant - 1O-Pack Delivery Tips

FDA Premarket Approval P100030 S014

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

Updates to the labeling to reflect a change in ownership and other minor updates to conform with current labeling standards

DevicePreveleak Surgical Sealant - 1O-Pack Delivery Tips
Generic NameSealant, Polymerizing
ApplicantBaxter Healthcare Corporation
Date Received2020-09-14
Decision Date2020-12-02
PMAP100030
SupplementS014
Product CodeNBE 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Baxter Healthcare Corporation one Baxter Parkway deerfield, IL 60015

Supplemental Filings

Supplement NumberDateSupplement Type
P100030Original Filing
S016 2021-11-10 30-day Notice
S015 2021-06-28 30-day Notice
S014 2020-09-14 Real-time Process
S013
S012
S011 2017-07-31 30-day Notice
S010 2017-07-26 30-day Notice
S009 2017-07-07 135 Review Track For 30-day Notice
S008 2017-07-03 Panel Track
S007 2017-05-30 Real-time Process
S006
S005 2016-07-26 Normal 180 Day Track No User Fee
S004 2014-05-22 Normal 180 Day Track No User Fee
S003
S002 2013-09-03 Real-time Process
S001 2013-09-03 Real-time Process

NIH GUDID Devices

Device IDPMASupp
25413765583609 P100030 013
25413765583593 P100030 013
25413765583586 P100030 013
25413765583524 P100030 014

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