FDA.reportPublic FDA data

IN.PACT™ AV

Primary DI
00763000232498
Brand
IN.PACT™ AV
Company
MEDTRONIC, INC.
Model
IAV04012008P
Device description
DCB IAV04012008P 04.00 L120 UL0800 US
Published
2019-12-06
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
PRCDrug-coated peripheral transluminal angioplasty catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRCDrug-Coated Peripheral Transluminal Angioplasty CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190008000
P190008004
P190008028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190008000IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterMedtronic Vascular, Inc.2019-11-21PRC
P190008004IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterMedtronic Vascular, Inc.2019-11-21PRC
P190008028IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterMedtronic Vascular, Inc.2019-11-21PRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000232498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000232498007630002324987630002324980763000232498

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
Length120Millimeter
Outer Diameter4Millimeter

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
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741202575Lutonix 035 Drug Coated Balloon PTA CatheterLUTONIX, INC.PRC2020-02-03
00801741187636LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187643LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187681LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187698LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187704LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187759LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187766LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00801741187803LUTONIX® Drug Coated BalloonLUTONIX, INC.PRC2020-01-31
00763000232719IN.PACT™ AVMEDTRONIC, INC.PRC2020-01-24
00763000232979IN.PACT™ AVMEDTRONIC, INC.PRC2020-01-24
00763000233235IN.PACT™ AVMEDTRONIC, INC.PRC2020-01-24
00763000232467IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232474IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232481IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232511IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232528IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232535IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232542IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232566IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232573IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232580IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232597IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232610IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232627IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232634IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232641IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232658IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232665IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06
00763000232672IN.PACT™ AVMEDTRONIC, INC.PRC2019-12-06