|
Device | PROTEGE GPS & RX CAROTID STENT SYSTEMS |
Generic Name | STENT, CAROTID |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P060001 |
Supplement Number | S002 |
Date Received | 01/31/2007 |
Decision Date | 07/17/2007 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCLUDE ALTERNATE PROCESS CHALLENGE DEVICES (PCD). |