Berlin Heart Inc

FDA Filings

This page includes the latest FDA filings for Berlin Heart Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Berlin Heart Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• BERLIN HEART GMBH

FDA Registration(s)

• Registration Number: 3008454189
• FEI Number: 3008454189
• Name: BERLIN HEART, INC.
• Owner & Operator: Berlin Heart, Inc.
• Contact Address: 9391 Grogan's Mill Road Suite A-6; The Woodlands TX 77380 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 9391 Grogan's Mill Road Suite A-6; The Woodlands, TX 77380 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMA P160035S023 Berlin Heart Inc.	EXCOR® Pediatric Ventricular Assist	2021-11-18
PMA P160035S022 Berlin Heart Inc.	EXCOR® Pediatric Ventricular Assist	2021-11-02
PMA P160035S021 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2021-10-20
PMA P160035S020 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2021-10-14
PMA P160035S019 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2021-01-13
PMA P160035S018 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2020-10-27
PMA P160035S017 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2020-10-23
PMA P160035S015 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2020-09-03
PMA P160035S014 Berlin Heart Inc.	EXCOR blood pumps with Injection Molded Housing	2020-05-06
PMA P160035S012 Berlin Heart Inc.	Excor Pediatric Ventricular Assist	2019-11-03
PMA P160035S011 Berlin Heart Inc.	Excor Pediatric Ventricular Assist	2019-11-03
PMA P160035S009 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2019-10-23
PMA P160035S007 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2019-09-18
PMA P160035S005 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2019-08-05
PMA P160035S004 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2018-10-26
PMA P160035S001 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2018-05-21
PMA P160035S003 Berlin Heart Inc.	EXCOR Blood Pump	2018-01-31
PMA P160035S002 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2017-08-02
PMN P160035 | DSQ BERLIN HEART, INC.	EXCOR? Pediatric Ventricular Assist Device	2017-06-30
PMA P160035 Berlin Heart Inc.	EXCOR Pediatric Ventricular Assist	2017-06-06

Similar & Related FDA Registered Companies

• Berlin 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
• Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS028 Date Received07/15/2022 Decision Date08/12/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS027 Date Received07/05/2022 Decision Date08/04/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS026 Date Received05/16/2022 Decision Date06/15/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS024 Date Received11/08/2021 Decision Date03/04/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	4YFL1	BERLIN HEART, INC.
CAGE Code	4YFL1	BERLIN HEART, INC.
S.A.M. Registration	4YFL1 [834355179]	BERLIN HEART, INC.