Excor Pediatric Ventricular Assist Device
FDA premarket approval P160035/S013 · decided 2020-09-23
Approval details
- PMA number
- P160035
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Excor Pediatric Ventricular Assist Device
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2020-01-24
- Decision date
- 2020-09-23
- Days to decision
- 243 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval for a design change to the polyurethane (PU) membrane and supplier/supplier production site change for the PU solutions.
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