PMA P060040S060
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S060
- Product code
- DSQ
- Decision date
- 2016-09-29
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for mechanical and marking modifications to the System Controller and Percutaneous Cable.
Current openFDA PMA Record#
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S060
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-09-29
- Decision code
- APPR
- Date received
- 2016-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for mechanical and marking modifications to the System Controller and Percutaneous Cable.