PMA P160035S002
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S002
- Product code
- DSQ
- Decision date
- 2017-08-02
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Manufacturing change for the cannulae used with the Berlin Heart EXCOR Pediatric VAD.
Current openFDA PMA Record#
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S002
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-08-02
- Decision code
- OK30
- Date received
- 2017-07-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change for the cannulae used with the Berlin Heart EXCOR Pediatric VAD.