EXCOR Cannula Clip
FDA premarket approval P160035/S049 · decided 2025-09-12
Approval details
- PMA number
- P160035
- Supplement
- S049
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXCOR Cannula Clip
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2025-03-17
- Decision date
- 2025-09-12
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval for the EXCOR Cannula Clip
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