PMA P970035S005

Device: MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S005
Product code: MAF
Decision date: 1998-09-30
Generic name: STENT, CORONARY
Approval order 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.

Current openFDA PMA Record

Device: MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S005
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1998-09-30
Decision code: OK30
Date received: 1998-09-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.