PMA P100047S124
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S124
- Product code
- DSQ
- Decision date
- 2018-08-06
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S124
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-08-06
- Decision code
- APPR
- Date received
- 2018-06-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.