PMA P100047S032
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S032
- Product code
- DSQ
- Decision date
- 2014-03-26
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A CHANGE OF THE THREAD LOCKING ADHESIVE USED ON THERETENTION NUT WHICH SECURES THE CONNECTOR TO THE CONTROLLER HOUSING.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S032
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-03-26
- Decision code
- APPR
- Date received
- 2013-12-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE OF THE THREAD LOCKING ADHESIVE USED ON THERETENTION NUT WHICH SECURES THE CONNECTOR TO THE CONTROLLER HOUSING.