Edwards Crimper model 9600CR
FDA premarket approval P140031/S041 · decided 2017-08-15
Approval details
- PMA number
- P140031
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Edwards Crimper model 9600CR
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2017-04-27
- Decision date
- 2017-08-15
- Days to decision
- 110 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for design modifications to the Edwards Crimper and for extending the shelf life of the Crimper to 2 years.
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