EXCOR Pediatric Ventricular Assist Device
Berlin Heart, Inc. · Ventricular (assist) bypass · Cardiovascular
Open FDA's page for this record- PMA number
- P160035
- Supplement number
- S054
- Applicant
- Berlin Heart, Inc.
- Street 1
- 9391 Grogan'S Mill Rd.
- Street 2
- Suite A-6
- City
- The Woodlands
- State
- TX
- Zip
- 77380
- Generic name
- Ventricular (assist) bypass
- Trade name
- EXCOR Pediatric Ventricular Assist Device
- Product code
- DSQ
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2025-11-21
- Decision date
- 2026-10-30
- Decision code
- APPR
- Ao statement
- approval for a change in the buffer solutions used during the blood pump coating process
- Harmonized identifiers (openFDA)
- Device name
- Ventricular (Assist) Bypass
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 2916596, 2031044, 2029275, 3012931014, 9612515, 3002807090, 3008454189, 3019807891, 2528981, 3004582654, 1319639, 3007042319, 1927395, 3011823740, 2133810, 3010163695, 2134470, 1721676, 3005228872, 1218444, 3003306248, 2182208, 3008792657
- FEI number
- 1000138054, 2916596, 3012931014, 1000306431, 3008454189, 3006003617, 3019807891, 2528981, 3004582654, 3002808437, 3007042319, 1927395, 3011823740, 3010163695, 3001236763, 1721676, 3000203066, 3005228872, 3002462840, 1218444, 3003306248, 2182208, 3008792657