PMA P060040S021
- Device
- THORATEC HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S021
- Product code
- DSQ
- Decision date
- 2012-06-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR THE HEARTMATE II UNIVERSAL PERCUTANEOUS BEND RELIEF REPAIR KIT.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S021
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2012-06-05
- Decision code
- APPR
- Date received
- 2012-05-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE HEARTMATE II UNIVERSAL PERCUTANEOUS BEND RELIEF REPAIR KIT.