Berlin Heart EXCOR Pediatric Ventricular Assist Device
FDA premarket approval P160035/S039 · decided 2024-04-18
Approval details
- PMA number
- P160035
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Berlin Heart EXCOR Pediatric Ventricular Assist Device
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2023-12-12
- Decision date
- 2024-04-18
- Days to decision
- 128 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- approval for revisions to the warning statements in the Instructions for Use
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