|
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 | S029 |
Date Received | 09/11/1997 |
Decision Date | 02/26/1998 |
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 |
Approval Order Statement Approval for Griffith Micro Science in Glens Falls, New York, to serve as the contract sterilization facility for th esterilization of the TK001 Photopheresis Procedural Kit, which is validated utilizing a biological indicator system internal to the product. |