BioGlue Surgical Adhesive

FDA Premarket Approval P010003 S040

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

DeviceBioGlue Surgical Adhesive
Generic NameGlue, Surgical, Arteries
ApplicantCRYOLIFE, INC.1655 Roberts Blvd., N.w.kennesaw, GA 30144 PMA NumberP010003 Supplement NumberS040 Date Received04/29/2022 Decision Date05/25/2022 Product Code MUQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-29
Decision Date2022-05-25
PMAP010003
SupplementS040
Product CodeMUQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCRYOLIFE, INC.
1655 Roberts Blvd., N.w.
kennesaw, GA 30144 PMA NumberP010003 Supplement NumberS040 Date Received04/29/2022 Decision Date05/25/2022 Product Code MUQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
an Alternative Irradiation Box And Configuration For Shipping Product, And A New Supplier For The Strong Ammonium Solution

Supplemental Filings

Supplement NumberDateSupplement Type
P010003Original Filing
S040 2022-04-29 30-day Notice
S039 2021-11-12 30-day Notice
S038 2021-06-25 30-day Notice
S037 2019-11-27 30-day Notice
S036 2019-07-23 30-day Notice
S035
S034
S033
S032 2018-12-07 30-day Notice
S031 2018-10-02 Special (immediate Track)
S030 2018-05-29 30-day Notice
S029 2017-12-05 30-day Notice
S028 2017-08-14 30-day Notice
S027 2017-07-24 Special (immediate Track)
S026
S025 2016-08-22 30-day Notice
S024 2016-06-14 30-day Notice
S023 2016-04-07 135 Review Track For 30-day Notice
S022 2016-04-04 30-day Notice
S021 2016-03-25 30-day Notice
S020 2016-03-08 30-day Notice
S019 2015-08-27 30-day Notice
S018
S017 2013-08-08 30-day Notice
S016 2012-01-10 Real-time Process
S015 2010-04-30 Special (immediate Track)
S014 2009-05-14 Real-time Process
S013 2008-09-16 Special (immediate Track)
S012 2008-06-06 30-day Notice
S011 2007-08-06 Real-time Process
S010 2007-04-20 Real-time Process
S009 2007-01-16 Special (immediate Track)
S008 2006-06-26 30-day Notice
S007 2005-10-31 Normal 180 Day Track
S006 2005-07-25 Normal 180 Day Track No User Fee
S005 2005-04-14 Real-time Process
S004 2004-09-21 Special (immediate Track)
S003 2004-03-17 Real-time Process
S002 2002-09-19 Normal 180 Day Track
S001 2002-05-03 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
10877234000253 P010003 001
00877234000249 P010003 001
00877234000232 P010003 001
10877234000154 P010003 005
00877234000188 P010003 005
10877234000192 P010003 005
10877234000178 P010003 006
00877234000164 P010003 006
10877234000260 P010003 016
00877234000270 P010003 016

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