PMA P160054S015
- Device
- HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S015
- Product code
- DSQ
- Decision date
- 2019-01-18
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval of the protocols for the post-approval studies protocol.
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S015
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-01-18
- Decision code
- APPR
- Date received
- 2018-11-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocols for the post-approval studies protocol.