PMA P060040S031
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S031
- Product code
- DSQ
- Decision date
- 2014-08-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO INCLUDE THE POST-APPROVAL STUDY RESULTS FOR THE DESTINATION THERAPY INDICATION AND TO ADD A DISCUSSION ON PUMP THROMBOSIS.
Current openFDA PMA Record#
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S031
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-08-05
- Decision code
- APPR
- Date received
- 2014-02-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO INCLUDE THE POST-APPROVAL STUDY RESULTS FOR THE DESTINATION THERAPY INDICATION AND TO ADD A DISCUSSION ON PUMP THROMBOSIS.