Portico™ Transcatheter Heart Valve

FDA Premarket Approval P190023 S004

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

Discontinuation of passive monitoring procedures in iso class 7 and 8 cleanrooms

DevicePortico™ Transcatheter Heart Valve
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantAbbott Medical
Date Received2021-11-08
Decision Date2021-12-16
PMAP190023
SupplementS004
Product CodeNPT 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
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

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.