Data / Medical devices / United States / Berlin Heart, Inc.
Berlin Heart, Inc.: FDA-registered device maker in The Woodlands, TX, United States, 1 PMA approval
Berlin Heart, Inc. is registered with the FDA (registration 3008454189) in The Woodlands, TX, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated June 6, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008454189
- Address
- 9391 Grogan's Mill Road Suite A-6, The Woodlands, TX, United States, 77380
- Owner or operator
- Berlin Heart, Inc. (10039498)
- Roles
- Complaint file establishment
- First device listed
- June 30, 2017
- Registered through
- 2027
- Brand names listed
- EXCOR® Pediatric Ventricular Assist Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventricular (Assist) Bypass | DSQ | 3 | Complaint file establishment | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 6, 2017 | P160035 | EXCOR Pediatric Ventricular Assist Device | DSQ | 55 | October 23, 2026 | accessdata.fda.gov |
Compare with other makers
Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.