AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM

FDA premarket approval P970035 · decided 1997-12-23

Approval details

PMA number

P970035

Trade name

AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

1997-08-05

Decision date

1997-12-23

Days to decision

140 days

Decision code

APWD

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

Approval for the AVE Micro Stent(TM) II Over-the-Wire Coronary Stent System and the AVE GFX(TM) Over-the-Wire Coronary Stent System. The devices are indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length < 30 mm) with a reference vessel diameter of 3.0 mm to 4.0 mm. Stenting is intended to improve coronary luminal diameter (see Individualization of Treatment). Long term outcome (beyond 6

510(k) clearances by this applicant