PMA P160035S001
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S001
- Product code
- DSQ
- Decision date
- 2018-05-21
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval of the protocol for the post-approval study protocol.
Current openFDA PMA Record#
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S001
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-05-21
- Decision code
- APPR
- Date received
- 2017-06-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the protocol for the post-approval study protocol.