PorticoTM Transcatheter Aortic Valve Implantation System

FDA Premarket Approval P190023 S010

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

DevicePorticoTM Transcatheter Aortic Valve Implantation System
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantAbbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS010 Date Received08/12/2022 Decision Date11/09/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-08-12
Decision Date2022-11-09
PMAP190023
SupplementS010
Product CodeNPT 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Medical
177 County Road B. East
st. Paul, MN 55117 PMA NumberP190023 Supplement NumberS010 Date Received08/12/2022 Decision Date11/09/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Modifications To The Packaging Design For The FlexNav Delivery System

Supplemental Filings

Supplement NumberDateSupplement Type
P190023Original Filing
S010 2022-08-12 Real-time Process
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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