EXCOR Connecting and Extension Sets
FDA premarket approval P160035/S050 · decided 2025-05-06
Approval details
- PMA number
- P160035
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXCOR Connecting and Extension Sets
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2025-04-15
- Decision date
- 2025-05-06
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- requested to remove manufacturing steps such that the connector and extension sets are no longer pre-connected
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