THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS

FDA premarket approval P970035/S028 · decided 2002-04-29

Approval details

PMA number

P970035

Supplement

S028

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

2001-05-11

Decision date

2002-04-29

Days to decision

353 days

Decision code

APPR

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR THE THUNDER HIGH SCAFFOLDING OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RX) SAPHENOUS VEIN GRAFT (SVG) STENT SYSTEMS; THE ADDITION OF A NEW MANUFACTURING FACILITY, AVE IRELAND LIMITED, GALWAY, IRELAND; AND THE ADDITION OF A NEW CONTRACT STERILIZER, IOTRON EBIS INDUSTRIES UK, LTD., OXFORDSHIRE, UNITED KINGDOM. THE DEVICES, WILL BE MARKETED UNDER THE TRADE NAMES OF THE THUNDER HIGH SCAFFOLDING OTW AND RX SVG STENT SYSTEMS, AND ARE INDICATED FOR IMPROVING VESSEL LUMINAL DIAMETER IN PATIEN

510(k) clearances by this applicant