PMA P160035S007
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S007
- Product code
- DSQ
- Decision date
- 2019-09-18
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a change in the material of the de-airing port.
Current openFDA PMA Record#
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S007
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-09-18
- Decision code
- APPR
- Date received
- 2019-06-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the material of the de-airing port.