|
Device | UVAR(R) XTS(R) 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 | S038 |
Date Received | 01/31/2001 |
Decision Date | 02/15/2001 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE USE OF DYMAX 29048 UV CURABLE ADHESIVE FOR SEALING THE TWO ACRYLIC PHOTOACTIVATION PLATES TO USING RADIO FREQUENCY WELDING. |