PMA P100047S154
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S154
- Product code
- DSQ
- Decision date
- 2020-05-05
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the addition of a new leak test requirement (IPX8 Per IEC60529) to the driveline connector and a 100% in process verification of this requirement.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S154
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-05-05
- Decision code
- APPR
- Date received
- 2020-02-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of a new leak test requirement (IPX8 Per IEC60529) to the driveline connector and a 100% in process verification of this requirement.