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 PHOTOPHORESIS 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 | S028 |
Date Received | 01/30/1997 |
Decision Date | 03/25/1997 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF EXTERNAL BIOLOGICAL INDICATORS TO MONITOR THE STERILIZATIN CYCLES FOR THE PHOTOPHERESIS TPS101 BLOOD TUBING SET, TPS102 PHOTOCEPTOR(R), AND A COMMERCIALLY AVAILABLE BLOOD CENTRIFUGE BOWL. |
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