Perceval Sutureless Heart Valve and Perceval PLUS Sutureless Heart Valve

FDA Premarket Approval P150011 S025

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

DevicePerceval Sutureless Heart Valve and Perceval PLUS Sutureless Heart Valve
Generic NameHeart-valve, Non-allograft Tissue
ApplicantCORCYM Canada Corp.5005 North Fraser Wayburnaby V5J 5 PMA NumberP150011 Supplement NumberS025 Date Received06/29/2022 Decision Date07/28/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-29
Decision Date2022-07-28
PMAP150011
SupplementS025
Product CodeLWR 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCORCYM Canada Corp.
5005 North Fraser Way
burnaby V5J 5 PMA NumberP150011 Supplement NumberS025 Date Received06/29/2022 Decision Date07/28/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Decrease In The Number Of Samples Used In The Limulus Amoebocyte Lysate Testing Performed Per Sterilization Batch

Supplemental Filings

Supplement NumberDateSupplement Type
P150011Original Filing
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
18022057015034 P150011 000
00896208000429 P150011 000
00896208000412 P150011 000
08022057014979 P150011 000
08022057014825 P150011 000
08022057014795 P150011 000
08022057014788 P150011 000
08022057014771 P150011 000
08022057014337 P150011 000
08022057014252 P150011 000
00896208000436 P150011 000
00896208000443 P150011 000
08022057014245 P150011 000
08022057014849 P150011 000
08022057014832 P150011 000
08022057014887 P150011 000
08022057014870 P150011 000
08022057014863 P150011 000
08022057014856 P150011 000
00896208000825 P150011 013
00896208000818 P150011 013
00896208000801 P150011 013
00896208000795 P150011 013

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