PMA P160035S008
- Device
- EXCOR IKUS Driver
- Applicant
- Berlin Heart, Inc.
- Product code
- DSQ
- Decision date
- 2020-02-20
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a change to implement and qualify a new supplier for the batteries in the IKUS Driving Unit.
Current openFDA PMA Record#
- Device
- EXCOR IKUS Driver
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S008
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-02-20
- Decision code
- APPR
- Date received
- 2019-07-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to implement and qualify a new supplier for the batteries in the IKUS Driving Unit.