EXCOR® Pediatric Ventricular Assist Device
FDA premarket approval P160035/S043 · decided 2024-06-05
Approval details
- PMA number
- P160035
- Supplement
- S043
- Supplement type
- 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
- 2024-05-07
- Decision date
- 2024-06-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- to change the manufacturing location for the cable harness component.
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