Biocor, Biocor Supra, Epic, and Epic Supra Valves

FDA Premarket Approval P040021 S043

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

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DeviceBiocor, Biocor Supra, Epic, and Epic Supra Valves
Generic NameHeart-valve, Non-allograft Tissue
ApplicantSt. Jude Medical, Inc.
Date Received2020-03-27
Decision Date2020-04-25
PMAP040021
SupplementS043
Product CodeLWR 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical, Inc. 177 E.county Rd. B East st Paul, MN 55117

Supplemental Filings

Supplement NumberDateSupplement Type
P040021Original Filing
S043 2020-03-27 30-day Notice
S042 2019-11-13 30-day Notice
S041 2019-05-09 30-day Notice
S040 2019-02-27 30-day Notice
S039 2019-02-13 30-day Notice
S038 2019-01-24 30-day Notice
S037 2018-10-24 Real-time Process
S036 2018-05-14 30-day Notice
S035 2018-03-27 30-day Notice
S034 2018-01-11 30-day Notice
S033 2017-11-28 30-day Notice
S032 2017-09-06 30-day Notice
S031
S030 2016-12-22 30-day Notice
S029 2016-07-01 30-day Notice
S028 2016-03-29 Normal 180 Day Track No User Fee
S027 2015-12-30 135 Review Track For 30-day Notice
S026 2015-01-21 30-day Notice
S025 2014-02-28 30-day Notice
S024 2013-06-10 135 Review Track For 30-day Notice
S023 2013-03-05 Real-time Process
S022 2012-04-17 Normal 180 Day Track No User Fee
S021 2012-03-22 Special (immediate Track)
S020 2011-08-17 Real-time Process
S019 2011-07-28 135 Review Track For 30-day Notice
S018 2011-06-06 135 Review Track For 30-day Notice
S017
S016 2011-01-06 Normal 180 Day Track No User Fee
S015 2010-10-18 Normal 180 Day Track No User Fee
S014 2010-09-30 Normal 180 Day Track No User Fee
S013 2010-09-30 30-day Notice
S012 2010-06-23 135 Review Track For 30-day Notice
S011 2009-08-17 Normal 180 Day Track No User Fee
S010 2009-08-14 30-day Notice
S009 2009-05-27 30-day Notice
S008 2009-03-27 Normal 180 Day Track No User Fee
S007 2008-07-31 Normal 180 Day Track
S006 2008-03-12 Normal 180 Day Track No User Fee
S005 2006-09-20 Normal 180 Day Track No User Fee
S004 2006-09-29 Panel Track
S003 2006-08-07 Normal 180 Day Track
S002
S001 2005-09-06 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
05414734055376 P040021 003
05414734055505 P040021 003
05414734055499 P040021 003
05414734055482 P040021 003
05414734055475 P040021 003
05414734055468 P040021 003
05414734055451 P040021 003
05414734055444 P040021 003
05414734055437 P040021 003
05414734055420 P040021 003
05414734055413 P040021 003
05414734055406 P040021 003
05414734055390 P040021 003
05414734055383 P040021 003
05414734055512 P040021 003
05414734055529 P040021 004
05414734055659 P040021 004
05414734055642 P040021 004
05414734055635 P040021 004
05414734055628 P040021 004
05414734055611 P040021 004
05414734055604 P040021 004
05414734055598 P040021 004
05414734055581 P040021 004
05414734055574 P040021 004
05414734055567 P040021 004
05414734055550 P040021 004
05414734055543 P040021 004
05414734055536 P040021 004
05414734055666 P040021 004

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