PMA P100047S018
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S018
- Product code
- DSQ
- Decision date
- 2013-04-02
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- CONDUCT LAL PYROGEN TESTING ON COMPONENTS OF THE LEFT VENTRICULAR ASSIST DEVICE OBTAINED FROM PRE-STERILE ASSEMBLY LOTS.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S018
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-04-02
- Decision code
- OK30
- Date received
- 2013-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CONDUCT LAL PYROGEN TESTING ON COMPONENTS OF THE LEFT VENTRICULAR ASSIST DEVICE OBTAINED FROM PRE-STERILE ASSEMBLY LOTS.