EDWARDS COMMANDER DELIVERY SYSTEM
FDA premarket approval P140031/S007 · decided 2016-02-22
Approval details
- PMA number
- P140031
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EDWARDS COMMANDER DELIVERY SYSTEM
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2016-02-08
- Decision date
- 2016-02-22
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for various design and manufacturing modifications to the Commander Delivery System.
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510(k) clearances by this applicant
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|---|---|---|
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| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
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| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |