EXCOR Pediatric Ventricular Assist Device
FDA premarket approval P160035/S016 · decided 2021-02-17
Approval details
- PMA number
- P160035
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- EXCOR Pediatric Ventricular Assist Device
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2020-08-31
- Decision date
- 2021-02-17
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval for updates to the Instructions for Use based on the post-approval study results.
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