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(TM) 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 | S037 |
Date Received | 07/07/2000 |
Decision Date | 01/05/2001 |
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 THE FOLLOWING SOFTWARE CHANGES: 1) REMOVAL OF SYSTEM ERROR F522:0000, 2) REMOVAL OF SYSTEM ERROR F581:0000, 3) CHANGE IN THE ALARM THRESHOLD FOR THE CENTRIFUGE BOWL VACUUM, AND 4) ADDITION OF NEW PRIMING STATE. |
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