EXCOR Pediatric Ventricular Assist Device
FDA premarket approval P160035/S025 · decided 2023-08-10
Approval details
- PMA number
- P160035
- Supplement
- S025
- 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
- 2022-02-23
- Decision date
- 2023-08-10
- Days to decision
- 533 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval of the addition of alternate cooling and lubricant oil used during the machining and milling process of the titanium connectors and adapters used in Berlin Heart EXCOR blood pumps.
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