|
Device | Therakos CELLEX Procedural Kit |
Generic Name | System, photopheresis, extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath Road Blanchardstown D15 T |
PMA Number | P860003 |
Supplement Number | S099 |
Date Received | 10/01/2018 |
Decision Date | 11/01/2018 |
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 | Yes |
Approval Order Statement Change in the device's manufacturing validation implementing the use of an automated inspection fixture that will inspect the integrity of 100% of all THERAKOS® CELLEX® Procedural Kit Centrifuge Outer Bowl welds. |