EXCOR® Apex Cannulae
FDA premarket approval P160035/S048 · decided 2025-03-11
Approval details
- PMA number
- P160035
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXCOR® Apex Cannulae
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2024-12-11
- Decision date
- 2025-03-11
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval for the addition of an injection molded manufacturing process for the EXCOR cannulae and to change the length of the cannulae velour.
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