EXCOR Pediatric Ventricular Assist

FDA Premarket Approval P160035 S031

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

DeviceEXCOR Pediatric Ventricular Assist
Generic NameVentricular (assist) Bypass
ApplicantBerlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS031 Date Received08/02/2022 Decision Date08/24/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-02
Decision Date2022-08-24
PMAP160035
SupplementS031
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBerlin Heart Inc.
9391 Grogan's Mill Road, Suite A-6
the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS031 Date Received08/02/2022 Decision Date08/24/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
changes In The Production Steps Of The Inflow And Outflow Valves Of The Berlin Heart EXCOR Pediatric VAD Blood Pump

Supplemental Filings

Supplement NumberDateSupplement Type
P160035Original Filing
S031 2022-08-02 30-day Notice
S030
S029
S028 2022-07-15 30-day Notice
S027 2022-07-05 30-day Notice
S026 2022-05-16 30-day Notice
S025
S024 2021-11-08 135 Review Track For 30-day Notice
S023 2021-10-20 30-day Notice
S022 2021-10-04 30-day Notice
S021 2021-09-21 30-day Notice
S020 2021-09-17 30-day Notice
S019 2020-12-14 30-day Notice
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

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