|
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 | S027 |
Date Received | 10/05/1995 |
Decision Date | 05/17/1996 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO CHANGE THE MANUFACTURING FACILITY FOR THE TPS102 PHOTOCEPTOR COMPONENT OF THE UVAR PHOTOPHERESIS SYSTEM FROM THERAKOS TO HARMAC MEDICAL PRODUCTS AT 2201 BAILEY AVENUE IN BUFFALO, NEW YORK (ESTABLISHMENT REGISTRATION #1317547) |