PMA P100047S101
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S101
- Product code
- DSQ
- Decision date
- 2017-12-15
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the addition of cleaning specifications and ongoing controls and monitoring requirements to verify compliance to the new cleanliness specifications.
Current openFDA PMA Record#
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S101
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-12-15
- Decision code
- APPR
- Date received
- 2017-06-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of cleaning specifications and ongoing controls and monitoring requirements to verify compliance to the new cleanliness specifications.