PMA P160035S023
- Device
- EXCOR® Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S023
- Product code
- DSQ
- Decision date
- 2021-11-18
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Add an output test, a cleaning step, and a visual inspection step prior to pump aeration.
Current openFDA PMA Record#
- Device
- EXCOR® Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S023
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-11-18
- Decision code
- OK30
- Date received
- 2021-10-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an output test, a cleaning step, and a visual inspection step prior to pump aeration.