PMA P160035S016
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- Product code
- DSQ
- Decision date
- 2021-02-17
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for updates to the Instructions for Use based on the post-approval study results.
Current openFDA PMA Record#
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S016
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-02-17
- Decision code
- APPR
- Date received
- 2020-08-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updates to the Instructions for Use based on the post-approval study results.