|
Device | UVAR XTS 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 | S035 |
Date Received | 12/20/1999 |
Decision Date | 01/14/2000 |
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 is for a new material, Codan Polypropylene RE764F/Cawiton, to be used in the body of the drip chamber of the UVAR XTS System's disposable set. |