Portico Transcatheter Aortic Heart Valve

FDA Premarket Approval P190023 S008

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

DevicePortico Transcatheter Aortic Heart Valve
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantAbbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS008 Date Received06/08/2022 Decision Date07/07/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-08
Decision Date2022-07-07
PMAP190023
SupplementS008
Product CodeNPT 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Medical
177 County Road B. East
st. Paul, MN 55117 PMA NumberP190023 Supplement NumberS008 Date Received06/08/2022 Decision Date07/07/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Addition Of A New Abattoir To Source Bovine Pericardium And A Change To The In-process Tissue Shelf Life

Supplemental Filings

Supplement NumberDateSupplement Type
P190023Original Filing
S009 2022-07-01 30-day Notice
S008 2022-06-08 30-day Notice
S007 2022-04-18 30-day Notice
S006 2022-02-18 30-day Notice
S005
S004 2021-11-08 30-day Notice
S003 2021-10-25 135 Review Track For 30-day Notice
S002
S001 2021-10-15 Normal 180 Day Track No User Fee

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