Solo Smart Heart Valve

FDA Premarket Approval P130011 S011

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

DeviceSolo Smart Heart Valve
Generic NameHeart-valve, Non-allograft Tissue
ApplicantCORCYM Canada Corp.5005 North Fraser Wayburnaby V5J 5 PMA NumberP130011 Supplement NumberS011 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
PMAP130011
SupplementS011
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 NumberP130011 Supplement NumberS011 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
P130011Original Filing
S011 2022-06-29 30-day Notice
S010 2022-03-03 30-day Notice
S009 2020-03-02 30-day Notice
S008 2020-01-13 30-day Notice
S007 2019-03-01 30-day Notice
S006 2018-02-07 30-day Notice
S005 2016-08-11 135 Review Track For 30-day Notice
S004 2016-03-31 30-day Notice
S003 2016-01-27 135 Review Track For 30-day Notice
S002 2015-12-07 135 Review Track For 30-day Notice
S001 2015-06-22 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00896208000498 P130011 000
00896208000481 P130011 000
00896208000474 P130011 000
00896208000467 P130011 000
00896208000405 P130011 000
00896208000399 P130011 000
00896208000382 P130011 000
00896208000375 P130011 000

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