PMA P100047S046
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S046
- Product code
- DSQ
- Decision date
- 2015-09-25
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S046
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2015-09-25
- Decision code
- APPR
- Date received
- 2014-05-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.