S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N

FDA premarket approval P970035/S038 · decided 2002-10-15

Approval details

PMA number

P970035

Supplement

S038

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

2002-04-23

Decision date

2002-10-15

Days to decision

175 days

Decision code

APPR

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR THE FOLLOWING TRADE NAMES AND EXPANDED DEVICE INDICATIONS: THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV2000 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <=30 MM) IN NATIVE CORONARY ARTERIES AND SAPHENOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION. LONG-TERM OUTCOME (BEY

510(k) clearances by this applicant