XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 33 mm / Rapid
XIENCE Skypoint™ - 1804500-33
Device Description
A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.
Environmental Conditions
- 30.00
- 15.00
- Store in a dry, dark, cool place. Protect from light. Do not remove from carton until ready for use. Store at 25°C (77°F); excursions permitted between 15-30°C(59-86°F).
- 25.00
- 25.00
Device Sizes
- Stent Diameter: 5 Millimeter
- Stent Length: 33 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NIQ
Device Name: Coronary Drug-Eluting Stent
Device Class: 3
Physical State: N/A
Definition: Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 08717648233678
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A