PMA P160035S027
- Device
- EXCOR® Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S027
- Product code
- DSQ
- Decision date
- 2022-08-04
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Removing the additional output test in the EXCOR blood pumps production line.
Current openFDA PMA Record#
- Device
- EXCOR® Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S027
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2022-08-04
- Decision code
- OK30
- Date received
- 2022-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removing the additional output test in the EXCOR blood pumps production line.