EXCOR Pediatric Ventricular Assist Device
FDA premarket approval P160035/S052 · decided 2025-07-24
Approval details
- PMA number
- P160035
- Supplement
- S052
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXCOR Pediatric Ventricular Assist Device
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2025-06-24
- Decision date
- 2025-07-24
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval for a predetermined change control plan (PCCP) that encompasses a change to introduce a new membrane model used in the compressors of the IKUS driving unit.
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