Pantera LEO

Basic Information

• Brand Name: Pantera LEO
• Primary DI: 07640130415751
• Version / Model: 3.0/15/145
• Catalog Number: 367017
• Company Name: Biotronik AG
• Labeler DUNS: 480862817
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-03
• Public Version: 4
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: ef5cfcee-586e-405a-8b0a-61f3526a9658

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOX	Catheters, transluminal coronary angioplasty, percutaneous	Cardiovascular	870.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47732	Coronary angioplasty balloon catheter, basic	A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640130415751	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163660	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Length: 15 mm
Device Size Text, specify			Diameter: 3 mm
Device Size Text, specify			Usable Length: 145 cm

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight Keep dry