S7 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM

FDA premarket approval P970035/S033 · decided 2002-04-24

Approval details

PMA number

P970035

Supplement

S033

Supplement type

135 Review Track For 30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

S7 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

2001-12-26

Decision date

2002-04-24

Days to decision

119 days

Decision code

APPR

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR THE ADDITION OF AN OPTIONAL MECHANICAL FIXATION STEP TO THE STENT SECUREMENT PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM AND IS INDICATED FOR THE IMPROVEMENT OF CORONARY LUMINAL DIAMETER.

510(k) clearances by this applicant