EXCOR Pediatric Ventricular Assist Device
FDA premarket approval P160035/S005 · decided 2019-08-05
Approval details
- PMA number
- P160035
- Supplement
- S005
- Supplement type
- Real-Time Process
- 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
- 2019-04-10
- Decision date
- 2019-08-05
- Days to decision
- 117 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval for a change in the wiring system at the nurse call relay switch of the EXCOR IKUS driver.
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