EXCOR Pediatric Ventricular Assist Device
FDA premarket approval P160035 · decided 2017-06-06
Approval details
- PMA number
- P160035
- Trade name
- EXCOR Pediatric Ventricular Assist Device
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2016-08-11
- Decision date
- 2017-06-06
- Days to decision
- 299 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval for the EXCOR® Pediatric Ventricular Assist Device (referred to as EXCOR Pediatric) is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR Pediatric.
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