EXCOR Pediatric Ventricular Assist

FDA Premarket Approval P160035 S017

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

An extension of excor blood pumps manufacturing area

DeviceEXCOR Pediatric Ventricular Assist
Generic NameVentricular (assist) Bypass
ApplicantBerlin Heart Inc.
Date Received2020-09-24
Decision Date2020-10-23
PMAP160035
SupplementS017
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Berlin Heart Inc. 9391 Grogan's Mill Road, Suite A-6 the Woodlands, TX 77380

Supplemental Filings

Supplement NumberDateSupplement Type
P160035Original Filing
S018 2020-09-28 30-day Notice
S017 2020-09-24 30-day Notice
S016
S015 2020-08-05 30-day Notice
S014 2020-04-06 30-day Notice
S013
S012 2019-10-11 30-day Notice
S011 2019-10-11 30-day Notice
S010
S009 2019-09-26 30-day Notice
S008
S007 2019-06-20 Normal 180 Day Track
S006
S005 2019-04-10 Real-time Process
S004 2018-09-28 30-day Notice
S003 2018-01-05 30-day Notice
S002 2017-07-14 30-day Notice
S001 2017-06-29 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
04260090041369 P160035 002
04260090040386 P160035 002
04260090040508 P160035 002
04260090040539 P160035 002
04260090041277 P160035 002
04260090041284 P160035 002
04260090041291 P160035 002
04260090041307 P160035 002
04260090041321 P160035 002
04260090041338 P160035 002
04260090041352 P160035 002
04260090040379 P160035 002

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.