PMA P100047S047
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S047
- Product code
- DSQ
- Decision date
- 2014-09-12
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR ADDING A TORQUE SPECIFICATION TO THE HVAD PUMP DESIGN SPECIFICATION DOCUMENT.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S047
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-09-12
- Decision code
- APPR
- Date received
- 2014-06-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ADDING A TORQUE SPECIFICATION TO THE HVAD PUMP DESIGN SPECIFICATION DOCUMENT.