S7 WITH DISCRETE TECHNOLOGY OVER-THE -WIRE CORONARY STENT SYSTEM/S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY

FDA premarket approval P970035/S036 · decided 2002-09-13

Approval details

PMA number

P970035

Supplement

S036

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

S7 WITH DISCRETE TECHNOLOGY OVER-THE -WIRE CORONARY STENT SYSTEM/S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

2002-03-25

Decision date

2002-09-13

Days to decision

172 days

Decision code

APPR

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR THE FOLLOWING EXPANDED DEVICE INDICATIONS: THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV 2000 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 WITH REFERENCE VESSEL DIAMETERS RANTING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION. LONG-TERM OUTCOME (BEYOND 180-DAYS) FOR THIS PERMANENT IMPLANT

510(k) clearances by this applicant