THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
FDA premarket approval P060040/S059 · decided 2017-06-23
Approval details
- PMA number
- P060040
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-05-24
- Decision date
- 2017-06-23
- Days to decision
- 395 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for the addition of an Intensive Care Unit (ICU) Cover accessory.
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