PREVELEAK Surgical Sealant

FDA Premarket Approval P100030 S015

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

A change in location for the quality control testing performed on the preveleak, from the baxter mountain view to baxter hayward facilities

DevicePREVELEAK Surgical Sealant
Generic NameSealant, Polymerizing
ApplicantBaxter Healthcare Corporation
Date Received2021-06-28
Decision Date2021-07-27
PMAP100030
SupplementS015
Product CodeNBE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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