PMA P100047S050
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S050
- Product code
- DSQ
- Decision date
- 2014-10-10
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- CHANGES TO THE PROCESS CHALLENGE DEVICE (PCD) USED FOR MONITORING THE ETHYLENE OXIDE STERILIZATION CYCLE OF THE STERILIZED COMPONENTS.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S050
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-10-10
- Decision code
- OK30
- Date received
- 2014-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE PROCESS CHALLENGE DEVICE (PCD) USED FOR MONITORING THE ETHYLENE OXIDE STERILIZATION CYCLE OF THE STERILIZED COMPONENTS.