PMA P160054S008
- Device
- HeartMate 3 Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S008
- Product code
- DSQ
- Decision date
- 2018-10-18
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the HeartMate 3 Left Ventricular Assist System. The device is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf16/P160054S008B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- HeartMate 3 Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S008
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-10-18
- Decision code
- APPR
- Date received
- 2018-05-03
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the HeartMate 3 Left Ventricular Assist System. The device is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.