PMA P160035S018
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S018
- Product code
- DSQ
- Decision date
- 2020-10-27
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Change the end of life and maintenance schedule of the manual air pump provided with each Ikus driving unit.
Current openFDA PMA Record#
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S018
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-10-27
- Decision code
- OK30
- Date received
- 2020-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the end of life and maintenance schedule of the manual air pump provided with each Ikus driving unit.