FDA.reportPublic FDA data

Edwards SAPIEN 3 transcatheter pulmonic valve delivery system

Primary DI
00690103221312
Brand
Edwards SAPIEN 3 transcatheter pulmonic valve delivery system
Company
Edwards Lifesciences LLC
Model
9631PL20A
Catalog number
9631PL20A
Device description
Pulmonic Delivery System - 20 mm (Gen 2) (US)
Published
2026-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPVPulmonary Valve Prosthesis Percutaneously Delivered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPVPulmonary Valve Prosthesis Percutaneously DeliveredUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200015068

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200015068Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemEdwards Lifesciences, LLC2020-08-31NPV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103221312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103221312006901032213126901032213120690103221312

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary transcatheter heart valve bioprosthesisAn implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is designed to be implanted with a catheter via vascular access. It may be attached to an expandable metal framework which may be expanded with a balloon or self-expand, and may include other material types (e.g., synthetic polymer). Devices associated with implantation (e.g., catheter, introducer) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter20Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9837tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103221329Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103221336Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103221343Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103210873EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM)Edwards Lifesciences LLCNPV2022-01-04
00690103210866THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEMEdwards Lifesciences LLCNPV2021-12-23
00763000338985Harmony™MEDTRONIC, INC.NPV2021-04-22
00763000338992Harmony™MEDTRONIC, INC.NPV2021-04-22
00763000341367Harmony™MEDTRONIC, INC.NPV2021-04-22
00643169713888Ensemble™ llMEDTRONIC, INC.NPV2016-10-31
00643169713895Ensemble™ llMEDTRONIC, INC.NPV2016-10-31
00643169713901Ensemble™ llMEDTRONIC, INC.NPV2016-10-31
00690103193930EDWARDS COMMANDER DELIVERY SYSTEMEdwards Lifesciences LLCNPV2015-07-05
00690103193947EDWARDS COMMANDER DELIVERY SYSTEMEdwards Lifesciences LLCNPV2015-07-05
00690103193954EDWARDS COMMANDER DELIVERY SYSTEMEdwards Lifesciences LLCNPV2015-07-05
00690103193961EDWARDS COMMANDER DELIVERY SYSTEMEdwards Lifesciences LLCNPV2015-07-05
00690103194005EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)Edwards Lifesciences LLCNPV2015-07-05
00690103194340EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)Edwards Lifesciences LLCNPV2015-07-05
00690103194357EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)Edwards Lifesciences LLCNPV2015-07-05
00690103194364EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)Edwards Lifesciences LLCNPV2015-07-05
00643169588189Melody™ TPVMEDTRONIC, INC.NPV2015-02-24
00643169588196Melody™ TPVMEDTRONIC, INC.NPV2015-02-24
00643169588431Ensemble™MEDTRONIC, INC.NPV2015-02-24
00643169588448Ensemble™MEDTRONIC, INC.NPV2015-02-24
00643169588455Ensemble™MEDTRONIC, INC.NPV2015-02-24
00643169298569Contegra®MEDTRONIC, INC.NPV2014-09-23
00643169415720ENSEMBLE™MEDTRONIC, INC.NPV2014-09-23
00643169415744ENSEMBLE™MEDTRONIC, INC.NPV2014-09-23
00643169415768ENSEMBLE™MEDTRONIC, INC.NPV2014-09-23
00643169415850Melody™ TPVMEDTRONIC, INC.NPV2014-09-23
00643169415874Melody™ TPVMEDTRONIC, INC.NPV2014-09-23