Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | DRIVER CORONARY STENT SYSTEM FAMILY OF PRODUCTS |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P030009 |
Supplement Number | S004 |
Date Received | 11/30/2005 |
Decision Date | 12/22/2005 |
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 CHANGE IN AN APPROVED SUPPLIER'S PROCESSING STEPS TO ALLOW THEM TO FURTHER PROCESS A SUBASSEMBLY IN ACCORDANCE WITH YOUR OWN MANUFACTURING OPERATIONS AND DEVICE SPECIFICATIONS. |
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