FDA.reportPublic FDA data

IN.PACT™ Admiral™

Primary DI
00643169383319
Brand
IN.PACT™ Admiral™
Company
MEDTRONIC, INC.
Model
ADM07006008P
Device description
DEB ADM07006008P 07.00 L060 UL0800 US
Published
2017-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONUDrug-Eluting Peripheral Transluminal Angioplasty CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140010000
P140010015
P140010017
P140010023
P140010032
P140010037
P140010043
P140010050
P140010051

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140010000IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU
P140010015IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU
P140010017IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU
P140010023IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU
P140010032IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU
P140010037IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU
P140010043IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU
P140010050IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU
P140010051IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169383319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169383319006431693833196431693833190643169383319

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, drug-coatedA sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store near radiation or ultraviolet light sources
Special Storage Condition, Specify00Keep Away from Sunlight
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Store the device in the original container.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150044177Concerto Versa™CVP-152026-10-18
00199150044184Concerto Versa™CVP-302026-10-18
00199150044191Concerto Versa™CVP-402026-10-18
00199150044207Concerto Versa™CVP-652026-10-18
00763000387020Symplicity G3™RDNG3A2023-11-30
00824846020073NABB10E56R162026-10-01
00643169845893Reveal LINQ™LNQ112020-01-19
00199150032402SenSight™B31030-S2026-09-28
00199150032426SenSight™B31030-D2026-09-28
00763000923709Power CordMCS1621PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506065577Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
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00191506065607Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065614Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065621Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065638Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065645Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065652Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065669Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065676Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065683Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065690Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065706Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065713Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065720Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065737Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065744Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065751Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065768Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065775Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065782Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065799Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065805Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065812Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065829Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065836Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065843Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065850Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14
00191506065867Ranger™BOSTON SCIENTIFIC CORPORATIONONU2026-10-14