|
Device | INTRACOIL PERIPHERAL STENT |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P000033 |
Supplement Number | S001 |
Date Received | 01/16/2004 |
Decision Date | 02/13/2004 |
Withdrawal Date
|
03/30/2018 |
Product Code |
NIP |
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 CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE WIRE POLISHING VENDOR FOR THE NITINOL WIRE POLISHING PROCESS. |