PMA P060040S011
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S011
- Product code
- DSQ
- Decision date
- 2010-09-13
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR UPDATED INSTRUCTIONS FOR USE (IFU) INCLUDING POST-APPROVAL STUDY RESULTS.
Current openFDA PMA Record#
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S011
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2010-09-13
- Decision code
- APPR
- Date received
- 2010-08-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATED INSTRUCTIONS FOR USE (IFU) INCLUDING POST-APPROVAL STUDY RESULTS.