PMA P060040S015
- Device
- THORATEC HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S015
- Product code
- DSQ
- Decision date
- 2012-06-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO REFLECT THE POST-APPROVAL STUDY FINDINGS FOR THE BRIDGE-TO-TRANSPLANT INDICATION.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S015
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2012-06-05
- Decision code
- APPR
- Date received
- 2012-02-13
- 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 REFLECT THE POST-APPROVAL STUDY FINDINGS FOR THE BRIDGE-TO-TRANSPLANT INDICATION.