PMA P970035S019

Device: S670 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S019
Product code: MAF
Decision date: 2000-05-11
Generic name: STENT, CORONARY
Approval order statement: Requesting that the three-step manufacturing process of the distal and intermediate tubing be reduced to a two-step manufacturing process of the distal and intermediate tubing be reduced to a two-step process whereby the forming step will be completely removed and the tubing will be extruded to the final dimensions.

Current openFDA PMA Record

Device: S670 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S019
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2000-05-11
Decision code: OK30
Date received: 2000-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Requesting that the three-step manufacturing process of the distal and intermediate tubing be reduced to a two-step manufacturing process of the distal and intermediate tubing be reduced to a two-step process whereby the forming step will be completely removed and the tubing will be extruded to the final dimensions.