MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX

Heart-valve, Non-allograft Tissue

FDA Premarket Approval P060038 S002

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 manufacturing process improvements to the aortic pericardial heart valve model 12. The device, as modified, will be marketed unde the trade name mitroflow aortic pericardial heart valve model lx and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

• Device: MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX
• Classification Name: Heart-valve, Non-allograft Tissue
• Generic Name: Heart-valve, Non-allograft Tissue
• Applicant: LivaNova Canada Corp.
• Date Received: 2008-12-29
• Decision Date: 2009-02-27
• PMA: P060038
• Supplement: S002
• Product Code: LWR
• Advisory Committee: Cardiovascular
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: LivaNova Canada Corp. 5005 North Fraser Way burnaby V5J 5

Supplemental Filings

Supplement Number	Date	Supplement Type
P060038		Original Filing
S033	2019-04-08	Normal 180 Day Track No User Fee
S032	2018-06-15	30-day Notice
S031	2017-12-26	135 Review Track For 30-day Notice
S030	2016-08-16	30-day Notice
S029	2016-08-11	135 Review Track For 30-day Notice
S028	2016-06-17	30-day Notice
S027	2016-03-31	30-day Notice
S026	2015-11-04	Real-time Process
S025	2015-09-28	Real-time Process
S024	2015-09-22	Real-time Process
S023	2015-03-27	30-day Notice
S022	2014-12-22	30-day Notice
S021	2014-09-22	Normal 180 Day Track No User Fee
S020	2014-05-16	Normal 180 Day Track No User Fee
S019	2014-02-24	30-day Notice
S018	2013-10-28	30-day Notice
S017	2013-07-01	Normal 180 Day Track
S016
S015	2012-10-04	30-day Notice
S014	2012-07-10	30-day Notice
S013
S012	2012-04-12	Normal 180 Day Track No User Fee
S011	2012-02-21	30-day Notice
S010	2011-07-22	135 Review Track For 30-day Notice
S009	2011-01-05	30-day Notice
S008	2010-12-23	30-day Notice
S007	2010-06-11	30-day Notice
S006	2009-07-22	30-day Notice
S005	2009-07-08	30-day Notice
S004	2009-05-27	135 Review Track For 30-day Notice
S003	2009-03-19	30-day Notice
S002	2008-12-29	Real-time Process
S001	2008-04-02	135 Review Track For 30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00896208000559	P060038	002
00896208000139	P060038	002
00896208000122	P060038	002
00896208000115	P060038	002
00896208000108	P060038	002
00896208000092	P060038	002
08022057014955	P060038	012
08022057014948	P060038	012
08022057014931	P060038	012
08022057014924	P060038	012
00896208000160	P060038	017
00896208000153	P060038	017
00896208000191	P060038	017
00896208000184	P060038	017
00896208000177	P060038	017
00896208000504	P060038	026
00896208000528	P060038	026
00896208000535	P060038	026
00896208000542	P060038	026
00896208000511	P060038	026