PMA P160054S020
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S020
- Product code
- DSQ
- Decision date
- 2019-08-25
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Add an alternate supplier for the Spline Pump Cover component.
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S020
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-08-25
- Decision code
- OK30
- Date received
- 2019-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for the Spline Pump Cover component.