|
Device | S670 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P970035 |
Supplement Number | S019 |
Date Received | 04/14/2000 |
Decision Date | 05/11/2000 |
Withdrawal Date
|
10/18/2010 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |