FDA.reportPublic FDA data

In.Pact™ 018

Primary DI
00763000291709
Brand
In.Pact™ 018
Company
MEDTRONIC, INC.
Model
IPU07004020P
Device description
DCB 018 IPU07004020P D7.0 L040 UL0200
Published
2022-08-13
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
P140010062
P140010079

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140010062IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxMedtronic, Inc.2014-12-30ONU
P140010079IN.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
00763000291709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000291709007630002917097630002917090763000291709

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
Balloon Diameter7Millimeter
Balloon Length40Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store the device in the original container. Do not store near radiation or ultraviolet light sources.
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
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04
00824846003687NABB4K20R42026-07-04
00824846003700NABB4645R212026-07-04
00824846001669NABB12T12R42026-06-28
00824846001843NA9S63R22026-06-28
00824846001850NA11U35R32026-06-28
00824846001614NABB12V43R32026-06-25
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150001811IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001828IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001842IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001859IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001873IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001880IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001903IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001910IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001934IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001941IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001965IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00199150001972IN.PACT™ 018MEDTRONIC, INC.ONU2026-03-19
00191506046613Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046620Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046637Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046644Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046651Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046668Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046675Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046682Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046699Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046705Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046712Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046729Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046736Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046743Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046750Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046767Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046774Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05
00191506046781Ranger™BOSTON SCIENTIFIC CORPORATIONONU2025-05-05