HeartMate 3 Left Ventricular Assist System (LVAS)
FDA premarket approval P160054/S007 · decided 2018-07-05
Approval details
- PMA number
- P160054
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartMate 3 Left Ventricular Assist System (LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-04-16
- Decision date
- 2018-07-05
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for introducing: 1) various design modifications to the Tunneling Adapter and Tunneling Lance; 2) various design modifications to the HeartMate 3 LVAD inner tray; and 3) a standalone packaging configuration for the modified Tunneling Adapter, with a shelf life of 3 years.
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