PMA P970035S012

Device: MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S012
Product code: MAF
Decision date: 1998-12-29
Generic name: STENT, CORONARY
Approval order 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.

Current openFDA PMA Record

Device: MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S012
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1998-12-29
Decision code: OK30
Date received: 1998-12-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.