SAPIEN 3 Ultra delivery system 9630TF20A

GUDID 00690103201239

Edwards SAPIEN 3 Ultra Delivery System (20mm) US

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID00690103201239
NIH Device Record Key730a7f4c-8ae9-41f6-a4d0-9d3da666df9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAPIEN 3 Ultra delivery system
Version Model Number9630TF20
Catalog Number9630TF20A
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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
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
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103201239 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-19
Device Publish Date2019-01-08

On-Brand Devices [SAPIEN 3 Ultra delivery system]

00690103201260U.S. Edwards SAPIEN 3 Ultra Delivery System (29mm)
0069010320125326mm SAPIEN 3 Ultra Delivery System
00690103201246U.S. Edwards SAPIEN 3 Ultra Delivery System (26mm)
00690103201239Edwards SAPIEN 3 Ultra Delivery System (20mm) US

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.