IN.PACT™ AV

Basic Information

• Brand Name: IN.PACT™ AV
• Primary DI: 00763000232917
• Version / Model: IAV08006004P
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-06
• Public Version: 2
• Public Version Date: 2021-02-25
• Public Version Status: Update
• Public Device Record Key: 3646d176-4876-4e5b-bf3d-50335b8c3753

Device Description

DCB IAV08006004P 08.00 L060 UL0400 US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PRC	Drug-coated peripheral transluminal angioplasty catheter	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62551	Peripheral angioplasty balloon catheter, drug-coated	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000232917	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P190008	000
P190008	004

Device Sizes

Type	Value	Unit	Text
Length	60.0	Millimeter
Outer Diameter	8.0	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Store the device in the original container. Do not store near radiation or ultraviolet light sources.