EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM) 9630PL29A

GUDID 00690103210873

SAPIEN 3 PULMONIC DELIVERY SYSTEM - 29MM (US)

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 ID00690103210873
NIH Device Record Keyd4e073af-1e81-427e-843f-fa58a34d7eff
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM)
Version Model Number9630PL29A
Catalog Number9630PL29A
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
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 Dimensions

Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter
Balloon Diameter29 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103210873 [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 Date2022-01-12
Device Publish Date2022-01-04

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00690103216981 - PASCAL2022-09-27 PASCAL TABLE US COMMERCIAL
00690103215793 - SAPIEN 3 Ultra RESILIA 2022-09-02 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 20mm
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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