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Transfemoral System Components
| Product Description | 23 mm valve | 26 mm valve | | Edwards SAPIEN Transcatheter Heart Valve with the RetroFlex 3 Transfemoral System | 9100RF323A | 9100RF326A |
 | | | | | | | Edwards SAPIEN Transcather Heart Valve | | RetroFlex 3 delivery system | | | RetroFlex balloon
catheter | | RetroFlex 3 introducer sheath set | | RetroFlex dialator kit | Atrion inflation device | Crimper | |
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CAUTION: Federal (United States) law restricts the Edwards SAPIEN transcatheter heart valve to sale by or on the order of a physician. This device has been approved by the FDA for specific indications for use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
CAUTION: Federal (United States) law restricts the RetroFlex 3 delivery system, RetroFlex 3 introducer sheath set, RetroFlex dilator kit, RetroFlex balloon catheter, crimper, and Atrion inflation device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
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