MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

FDA premarket approval P970035/S005 · decided 1998-09-30

Approval details

PMA number

P970035

Supplement

S005

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

1998-09-18

Decision date

1998-09-30

Days to decision

12 days

Decision code

OK30

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

Requested a change to utilize a circular "ring" light source to apply the UV light during the UV adhesive curing process. The requested change will provide constant 360 degree application of UV light to the UV adhesive and will no longer require rotation of the catheter assembly. This process change will eliminate the need for nitrogen cooling gas and will reduce the process time for the distal luer bond from 60 seconds to 38 seconds.

510(k) clearances by this applicant