Edwards Certitude Introducer Sheath Set, Models 9600IS18, 9600IS21
FDA premarket approval P140031/S069 · decided 2018-07-15
Approval details
- PMA number
- P140031
- Supplement
- S069
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Edwards Certitude Introducer Sheath Set, Models 9600IS18, 9600IS21
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2018-07-02
- Decision date
- 2018-07-15
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Implement a change to the formulation of the mold release agent used in the production of the introducers in the Edwards Certitude introducer sheath sets.
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