Perceval Sutureless Heart Valve, Perceval PLUS

FDA Premarket Approval P150011 S022

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 new sub-supplier for sutures used in perceval devices

DevicePerceval Sutureless Heart Valve, Perceval PLUS
Generic NameHeart-valve, Non-allograft Tissue
ApplicantLivaNova Canada Corp.
Date Received2021-02-16
Decision Date2021-03-17
PMAP150011
SupplementS022
Product CodeLWR 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address LivaNova Canada Corp. 5005 North Fraser Way burnaby V5J 5

Supplemental Filings

Supplement NumberDateSupplement Type
P150011Original Filing
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
18022057015034 P150011 000
00896208000429 P150011 000
00896208000436 P150011 000
00896208000443 P150011 000
00896208000412 P150011 000
08022057014856 P150011 000
08022057014863 P150011 000
08022057014870 P150011 000
08022057014887 P150011 000
08022057014832 P150011 000
08022057014849 P150011 000
00896208000818 P150011 013
00896208000801 P150011 013
00896208000795 P150011 013
00896208000825 P150011 013

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