Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System

FDA Premarket Approval P190023 S001

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 of the protocol for the post approval study "registry-based real world use surveillance of the portico tavi system. "

DevicePortico Heart Valve, FlexNav Delivery System, FlexNav Loading System
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantAbbott Medical
Date Received2021-10-15
Decision Date2021-11-12
PMAP190023
SupplementS001
Product CodeNPT 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 177 County Road B. East st. Paul, MN 55117

Supplemental Filings

Supplement NumberDateSupplement Type
P190023Original Filing
S001 2021-10-15 Normal 180 Day Track No User Fee

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