PreveLeak Surgical Sealant / PreveLeak Surgical 10pk applicator tips

Sealant, Polymerizing

FDA Premarket Approval P100030 S011

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

Use of two roller bottles for each of the syringe’s solutions into the filler machine.

DevicePreveLeak Surgical Sealant / PreveLeak Surgical 10pk applicator tips
Classification NameSealant, Polymerizing
Generic NameSealant, Polymerizing
ApplicantBaxter Healthcare Corporation
Date Received2017-07-31
Decision Date2017-08-30
PMAP100030
SupplementS011
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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