Perceval Heart Valve

Heart-valve, Non-allograft Tissue

FDA Premarket Approval P150011 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

Approval for labeling changes implemented to provide safety information regarding future valve in valve implantations.

DevicePerceval Heart Valve
Classification NameHeart-valve, Non-allograft Tissue
Generic NameHeart-valve, Non-allograft Tissue
ApplicantLivaNova Canada Corp.
Date Received2018-12-10
Decision Date2019-01-08
PMAP150011
SupplementS014
Product CodeLWR
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address LivaNova Canada Corp. 5005 North Fraser Way burnaby V5J 5

Supplemental Filings

Supplement NumberDateSupplement Type
P150011Original Filing
S026 2022-10-24 30-day Notice
S025 2022-06-29 30-day Notice
S024
S023 2022-03-03 30-day Notice
S022 2021-02-16 30-day Notice
S021
S020 2020-03-16 Real-time Process
S019 2020-03-02 30-day Notice
S018 2020-01-13 30-day Notice
S017 2019-10-17 30-day Notice
S016 2019-03-01 30-day Notice
S015 2019-01-22 Special (immediate Track)
S014 2018-12-10 Special (immediate Track)
S013
S012 2018-02-07 30-day Notice
S011 2017-07-24 135 Review Track For 30-day Notice
S010 2017-06-26 30-day Notice
S009 2017-02-16 30-day Notice
S008 2017-01-27 30-day Notice
S007 2017-01-19 30-day Notice
S006 2016-12-15 Special (immediate Track)
S005 2016-08-11 135 Review Track For 30-day Notice
S004 2016-04-06 30-day Notice
S003 2016-03-31 30-day Notice
S002 2016-01-27 135 Review Track For 30-day Notice
S001 2016-01-27 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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08022057014979 P150011 000
08022057014825 P150011 000
08022057014795 P150011 000
08022057014788 P150011 000
08022057014771 P150011 000
08022057014337 P150011 000
08022057014252 P150011 000
08022057014245 P150011 000
08022057015563 P150011 000
08022057015556 P150011 000
08022057015549 P150011 000
00896208000412 P150011 000
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00896208000436 P150011 000
08022057014849 P150011 000
08022057014832 P150011 000
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08022057014870 P150011 000
08022057014863 P150011 000
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00896208000443 P150011 000
08022057015532 P150011 000
00896208000825 P150011 013
00896208000818 P150011 013
00896208000801 P150011 013
00896208000795 P150011 013

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