FDA.reportPublic FDA data

PipelineTM Vantage Embolization Device with Shield TechnologyTM

Primary DI
00847536036499
Brand
PipelineTM Vantage Embolization Device with Shield TechnologyTM
Company
Micro Therapeutics, Inc.
Model
PED3-021-350-10
Device description
STENT PED3-021-350-10 V03 VANTAGE
Published
2023-12-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUTIntracranial aneurysm flow diverter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUTIntracranial Aneurysm Flow DiverterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100018034

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100018034PIPELINE EMBOLIZATION DEVICEMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2011-04-06OUT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536036499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536036499008475360364998475360364990847536036499

Contacts#

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

Regulatory Flags#

DUNS number
826110710
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536003446Echelon103-50952015-10-23
00763000541194RistTM106F-071-952022-05-01
00763000541200RistTM106F-071-1002022-05-01
00763000541217RistTM106F-071-1052022-05-01
00763000413767Rist™107F-079-952020-10-05
00763000413774Rist™107F-079-1002020-10-05
00763000413781Rist™107F-079-1052020-10-05
00763000413798Rist™105F-BER-1202020-10-05
00763000413804Rist™105F-BER-1302020-10-05
00763000413811Rist™105F-SIM-1202020-10-05
00763000413828Rist™105F-SIM-1302020-10-05
00763000399641PhenomTM 17 CatheterFG11150-0615-2J2021-04-26
00763000399658PhenomTM 17 CatheterFG11150-0615-2R2021-04-26
00763000399665PhenomTM 17 CatheterFG11150-0615-2S2021-04-26
00763000399672PhenomTM 17 CatheterFG11150-0615-2X2021-04-26
00763000399689PhenomTM 21 CatheterFG13150-0615-2S2021-04-26
00763000399702PhenomTM 27 CatheterFG15150-0615-1S2021-04-26
00763000399719PhenomTM 27 CatheterFG15150-0630-1S2021-04-26
00763000399733PhenomTM Plus CatheterFG19120-1030-1S2021-04-26
00847536041967REACT™REACT-682021-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429106570StentMicrovention, Inc.OUT2025-04-22
00842429106587StentMicrovention, Inc.OUT2025-04-22
00842429106594StentMicrovention, Inc.OUT2025-04-22
00842429106600StentMicrovention, Inc.OUT2025-04-22
00842429106617StentMicrovention, Inc.OUT2025-04-22
00842429106624StentMicrovention, Inc.OUT2025-04-22
00842429106631StentMicrovention, Inc.OUT2025-04-22
00842429106648StentMicrovention, Inc.OUT2025-04-22
00842429106655StentMicrovention, Inc.OUT2025-04-22
00842429106662StentMicrovention, Inc.OUT2025-04-22
00842429106679StentMicrovention, Inc.OUT2025-04-22
00842429106686StentMicrovention, Inc.OUT2025-04-22
00842429106693StentMicrovention, Inc.OUT2025-04-22
00842429106709StentMicrovention, Inc.OUT2025-04-22
00842429106723StentMicrovention, Inc.OUT2025-04-22
00842429106730StentMicrovention, Inc.OUT2025-04-22
00842429106747StentMicrovention, Inc.OUT2025-04-22
00842429106754StentMicrovention, Inc.OUT2025-04-22
00842429106761StentMicrovention, Inc.OUT2025-04-22
00842429106778StentMicrovention, Inc.OUT2025-04-22
00842429106785StentMicrovention, Inc.OUT2025-04-22
00842429106792StentMicrovention, Inc.OUT2025-04-22
00842429106808StentMicrovention, Inc.OUT2025-04-22
00842429106815StentMicrovention, Inc.OUT2025-04-22
00842429106822StentMicrovention, Inc.OUT2025-04-22
00842429106839StentMicrovention, Inc.OUT2025-04-22
00842429106846StentMicrovention, Inc.OUT2025-04-22
00842429106853StentMicrovention, Inc.OUT2025-04-22
00842429106860StentMicrovention, Inc.OUT2025-04-22
00763000448929Pipeline TM Flex Embolization Device with Shield Technology TMMicro Therapeutics, Inc.OUT2025-03-11