THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM 29AP4045A

GUDID 00690103210866

ALTERRA ADAPTIVE PRESTENT SYSTEM (US) 40MM X 48MM

Edwards Lifesciences LLC

Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis
Primary Device ID00690103210866
NIH Device Record Key3241c6d4-749c-45b7-94dd-d6c60fe5fb68
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM
Version Model Number29AP4045
Catalog Number29AP4045A
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 Datetrue
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100690103210866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPVPulmonary Valve Prosthesis Percutaneously Delivered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-31
Device Publish Date2021-12-23

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00690103215809 - SAPIEN 3 Ultra RESILIA2022-09-02 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 23mm
00690103215816 - SAPIEN 3 Ultra RESILIA 2022-09-02 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 26mm

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