Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve

FDA Premarket Approval P150011 S020

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 related to sizing instructions for the perceval sutureless heart valve.

DevicePerceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
Generic NameHeart-valve, Non-allograft Tissue
ApplicantLivaNova Canada Corp.
Date Received2020-03-16
Decision Date2020-06-11
PMAP150011
SupplementS020
Product CodeLWR 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
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
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
18022057015034 P150011 000
08022057014849 P150011 000
08022057014832 P150011 000

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