PMA P100047S073
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S073
- Product code
- DSQ
- Decision date
- 2016-03-22
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Modification to the approved internal process challenge device (PCD) utilized for the sterilization process verification of the HeartWare Ventricular Assist System.
Current openFDA PMA Record#
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S073
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-03-22
- Decision code
- OK30
- Date received
- 2016-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the approved internal process challenge device (PCD) utilized for the sterilization process verification of the HeartWare Ventricular Assist System.