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 | UVAR XTS PHOTOPHERESIS SYSTEM |
Generic Name | System, photopheresis, extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath Road Blanchardstown D15 T |
PMA Number | P860003 |
Supplement Number | S031 |
Date Received | 08/05/1998 |
Decision Date | 08/10/1999 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for engineering changes to the UVAR(R) Photopheresis System including the following: 1) Replacing the obsolete Haemotronics centrifuge assembly with the current generation Haemotronics centrifuge assembly that includes an optical detector; 2) Replacing the electronic roller pumps and mechanical clamps with a pneumatically-driven fluid management system, including the cassette, fluid logic module and fluid logic controller; 3) Modifying the Photoceptor(R) photoactivation chamber; 4) Redesigning the treatment kit; and 5) Redesigning the user interface and system software. The device is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug methoxsalen (8-methoxypsoralen or 8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other therapy. |
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