MEDTRONIC AVE S7 ZIPPER MX CORONARY STENT SYSTEM

FDA premarket approval P970035/S043 · decided 2002-10-28

Approval details

PMA number

P970035

Supplement

S043

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

MEDTRONIC AVE S7 ZIPPER MX CORONARY STENT SYSTEM

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

2002-10-18

Decision date

2002-10-28

Days to decision

10 days

Decision code

APPR

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR THE ADDITION OF TWO NEW INDICATIONS FOR THE MEDTRONIC AVE S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM, SPECIFICALLY FOR DIRECT STENTING AND FOR THE TREATMENT OF SAPHENOUS VEIN GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC AVE S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM AND 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 A

510(k) clearances by this applicant