PMA P160035S005
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S005
- Product code
- DSQ
- Decision date
- 2019-08-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a change in the wiring system at the nurse call relay switch of the EXCOR IKUS driver.
Current openFDA PMA Record#
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S005
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-08-05
- Decision code
- APPR
- Date received
- 2019-04-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the wiring system at the nurse call relay switch of the EXCOR IKUS driver.