PMA P100047S112
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S112
- Product code
- DSQ
- Decision date
- 2018-07-10
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a label expansion to include the thoracotomy surgical procedure.
Current openFDA PMA Record#
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S112
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-07-10
- Decision code
- APPR
- Date received
- 2017-10-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a label expansion to include the thoracotomy surgical procedure.