PMA P100047S064
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S064
- Product code
- DSQ
- Decision date
- 2016-01-15
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:MODIFIED RANKIN SCORE (MRS) VALIDATION PLAN.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S064
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-01-15
- Decision code
- APPR
- Date received
- 2015-07-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:MODIFIED RANKIN SCORE (MRS) VALIDATION PLAN.