PMA P060040S023
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S023
- Product code
- DSQ
- Decision date
- 2013-05-07
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A NEW SYSTEM CONTROLLER FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S023
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-05-07
- Decision code
- APPR
- Date received
- 2012-06-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW SYSTEM CONTROLLER FOR THE DEVICE.