Excor Pediatric Ventricular Assist

Ventricular (assist) Bypass

FDA Premarket Approval P160035 S012

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

To raise the comparator threshold value for buzzer board for ikus driver

DeviceExcor Pediatric Ventricular Assist
Classification NameVentricular (assist) Bypass
Generic NameVentricular (assist) Bypass
ApplicantBerlin Heart Inc.
Date Received2019-10-11
Decision Date2019-11-03
PMAP160035
SupplementS012
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
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

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