EXCOR Pediatric Ventricular Assist Device
FDA premarket approval P160035/S021 · decided 2021-10-20
Approval details
- PMA number
- P160035
- Supplement
- S021
- 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
- 2021-09-21
- Decision date
- 2021-10-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- changes to the test program in the software used to determine the roughness of sloping and curved surfaces of the titanium connectors and adapters of the connecting and extension sets for the EXCOR blood pumps
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