ABIOMED ARTERIAL CANNULA
FDA premarket approval P900023/S050 · decided 2008-09-18
Approval details
- PMA number
- P900023
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABIOMED ARTERIAL CANNULA
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2008-08-19
- Decision date
- 2008-09-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- CHANGE FROM A COATING PROCEDURE PERFORMED AT AN OUTSIDE VENDOR TO A COATING PROCEDURE PERFORMED AT ABIOMED.
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