Avalus Bioprosthesis

FDA Premarket Approval P170006 S018

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 an updated protocol and additional testing performed for shelf-life extension.

DeviceAvalus Bioprosthesis
Generic NameHeart-valve, Non-allograft Tissue
ApplicantMedtronic Inc.
Date Received2020-10-02
Decision Date2020-10-22
PMAP170006
SupplementS018
Product CodeLWR 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Inc. 1851 E. Deere Avenue santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P170006Original Filing
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

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