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. |
|
Device | INTEGRITY CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P030009 |
Supplement Number | S054 |
Date Received | 04/11/2011 |
Decision Date | 06/09/2011 |
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 FOR ADDITION OF LABELING REGARDING SIMULTANEOUS USE OF THE INTEGRITY RX STENT SYSTEM WITH EITHER ANOTHER INTEGRITY RX STENT SYSTEM, OR WITH A SPRINTER LEGEND RX BALLOON DILATION CATHETER. IN ADDITION, APPROVAL TO REVISE THE MRI COMPATIBILITY INFORMATION IN THE LABELING. |
|
|