AB PORTABLE DRIVER
FDA premarket approval P900023/S049 · decided 2009-03-17
Approval details
- PMA number
- P900023
- Supplement
- S049
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AB PORTABLE DRIVER
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2008-08-01
- Decision date
- 2009-03-17
- Days to decision
- 228 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR IN-HOSPITAL USE OF THE DEVICE.
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