SAPIEN 3 Ultra System 9750CM23A

GUDID 00690103207828

SAPIEN 3 Ultra valve with Commander delivery System

Edwards Lifesciences LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework
Primary Device ID00690103207828
NIH Device Record Keyf792b4d5-ca30-4727-9ead-08a37a2e6f33
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAPIEN 3 Ultra System
Version Model Number9750CM23
Catalog Number9750CM23A
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
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Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
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Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
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Phone+1(800)822-9637
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Device Dimensions

Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103207828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPUProsthesis, Mitral Valve, Percutaneously Delivered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-09
Device Publish Date2019-08-30

On-Brand Devices [SAPIEN 3 Ultra System ]

00690103207835SAPIEN 3 Ultra valve with Commander Delivery System
00690103207828SAPIEN 3 Ultra valve with Commander delivery System
00690103207811SAPIEN 3 Ultra valve with Commander Delivery System
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