IN.PACT™ Admiral™

Basic Information

• Brand Name: IN.PACT™ Admiral™
• Primary DI: 00643169576346
• Version / Model: ADM06015008P
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-03
• Public Version: 6
• Public Version Date: 2021-05-27
• Public Version Status: Update
• Public Device Record Key: 9cc47f8c-7ab4-4fa9-85ee-61a7c06776ad

Device Description

DEB ADM06015008P 06.00 L150 UL0800 US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
ONU	Drug-Eluting 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	00643169576346	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P140010	013
P140010	015
P140010	023
P140010	032
P140010	037
P140010	043
P140010	050
P140010	051

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Balloon Length 150 MM
Device Size Text, specify			Balloon Diameter 6 MM

Storage Conditions

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