AVALUS(TM) BIOPROSTHESIS

Heart-valve, Non-allograft Tissue

FDA Premarket Approval P170006

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the avalus bioprosthesis, model 400. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

DeviceAVALUS(TM) BIOPROSTHESIS
Classification NameHeart-valve, Non-allograft Tissue
Generic NameHeart-valve, Non-allograft Tissue
ApplicantMedtronic Inc.
Date Received2017-02-02
Decision Date2017-07-31
Notice Date2017-08-08
PMAP170006
SupplementS
Product CodeLWR
Docket Number17M-4756
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Inc. 1851 E. Deere Avenue santa Ana, CA 92705
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P170006Original Filing
S021 2022-07-20 30-day Notice
S020 2022-02-28 30-day Notice
S019 2020-11-25 30-day Notice
S018 2020-10-02 Real-time Process
S017 2020-08-03 30-day Notice
S016 2019-09-26 Real-time Process
S015 2019-06-20 30-day Notice
S014 2019-05-31 30-day Notice
S013
S012 2019-05-03 30-day Notice
S011 2019-04-18 30-day Notice
S010 2019-01-29 30-day Notice
S009 2019-01-24 30-day Notice
S008 2018-11-21 30-day Notice
S007
S006 2018-07-27 30-day Notice
S005 2017-11-22 30-day Notice
S004 2017-10-23 30-day Notice
S003 2017-10-18 30-day Notice
S002
S001 2017-09-11 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169983212 P170006 000
00643169983205 P170006 000
00643169983199 P170006 000
00643169983182 P170006 000
00643169983175 P170006 000
00643169983229 P170006 024
00763000647032 P170006 025
00763000647049 P170006 025
00763000647056 P170006 025
00763000647063 P170006 025
00763000647070 P170006 025
00763000647025 P170006 025

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