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 | THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY , |
Generic Name | System, photopheresis, extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath Road Blanchardstown D15 T |
PMA Number | P860003 |
Supplement Number | S067 |
Date Received | 09/27/2012 |
Decision Date | 11/19/2012 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR SOME MINOR CHANGES INTENDED TO REDUCE SPECULAR REFLECTION OF THE KT8L SENSOR'S LASER BEAM AND IMPROVE ITS OPTIC PATH (E.G., REMOVAL OF GLASS PORT, REMOVAL OF RESISTOR, AND ADDITION OF GASKET). |
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