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 | INTEGRITY CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P030009 |
Supplement Number | S058 |
Date Received | 08/08/2011 |
Decision Date | 09/07/2011 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE MAXIMUM STENT INNER DIAMETER (MSID) FOR THE MEDIUM VESSEL STENT SIZES (3.0 MM TO 4.0 MM DIAMETERS) FROM 4.75 MM TO 5.0 MM. |
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