FDA.reportPublic FDA data

Protégé™ GPS™

Primary DI
00821684071403
Brand
Protégé™ GPS™
Company
EV3, INC
Model
SERB65-09-20-80
Device description
STENT SERB65-09-20-80 PROTEGE GPS V05
Published
2015-09-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGECATHETER, BILIARY, DIAGNOSTIC
NIOSTENT, ILIAC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2
NIOStent, IliacUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021729000
K032580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021729000MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGYSulzer Intratherapeutics, Inc.2002-06-21FGE
K032580000PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEMEv3, Inc.2003-10-22FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821684071403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684071403008216840714038216840714030821684071403

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal biliary stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length20Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
117446916
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150028399Liberant™LMT-TRX2026-05-07
00821684071397Protégé™ GPS™SERB65-09-20-1202015-09-04
00821684071410Protégé™ GPS™SERB65-09-30-1202015-09-04
00821684071427Protégé™ GPS™SERB65-09-30-802015-09-04
00821684071434Protégé™ GPS™SERB65-09-40-1202015-09-04
00821684071441Protégé™ GPS™SERB65-09-40-802015-09-04
00821684071458Protégé™ GPS™SERB65-09-60-1202015-09-04
00821684071465Protégé™ GPS™SERB65-09-60-802015-09-04
00821684071472Protégé™ GPS™SERB65-09-80-1202015-09-04
00821684071489Protégé™ GPS™SERB65-09-80-802015-09-04
00821684071496Protégé™ GPS™SERB65-10-20-1202015-09-01
00821684071502Protégé™ GPS™SERB65-10-20-802015-09-01
00821684071519Protégé™ GPS™SERB65-10-30-1202015-09-01
00821684071526Protégé™ GPS™SERB65-10-30-802015-09-01
00821684071533Protégé™ GPS™SERB65-10-40-1202015-09-01
00821684071540Protégé™ GPS™SERB65-10-40-802015-09-01
00821684071557Protégé™ GPS™SERB65-10-60-1202015-09-01
00821684071564Protégé™ GPS™SERB65-10-60-802015-09-01
00821684071571Protégé™ GPS™SERB65-10-80-1202015-09-01
00821684071588Protégé™ GPS™SERB65-10-80-802015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15