Certitude Introducer sheath set and Crimper
FDA premarket approval P140031/S081 · decided 2019-02-18
Approval details
- PMA number
- P140031
- Supplement
- S081
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Certitude Introducer sheath set and Crimper
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2019-02-08
- Decision date
- 2019-02-18
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Addition of a new cleanroom for the manufacture of the Certitude Introduce sheath set and Crimper.
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