MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM

FDA premarket approval P970035/S012 · decided 1998-12-29

Approval details

PMA number

P970035

Supplement

S012

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

1998-12-11

Decision date

1998-12-29

Days to decision

18 days

Decision code

OK30

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

The 30-Day Notice requested to add an additional step in the manufacturing of multilumen tubing. The additional step would consist of compounding the virgin resin HDPE/Black-Colorant blend prior to the extrusion of multilumen tubing by AVE. The compounding will be done by a vendor via machine mixing, extruded and then re-pelletized to provide compounded resin pellets of the blend required for extrusion of AVE's multilumen tubing.

510(k) clearances by this applicant