- Device
- EXCOR blood pumps with Injection Molded Housing
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S014
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-05-06
- Decision code
- OK30
- Date received
- 2020-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement changes for injection molding of the blood pump housing and modifications to the stabilization ring, de-airing port, and driving tube connection.