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Device | THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK |
Generic Name | System, photopheresis, extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath Road Blanchardstown D15 T |
PMA Number | P860003 |
Supplement Number | S110 |
Date Received | 07/14/2023 |
Decision Date | 08/10/2023 |
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 to qualify a new core for the drive tube injection mold tool used to manufacture the O-ring sealing gland of the THERAKOS® CELLEX® Procedural Kit, which will also alter the cavity insert for the molding process from P20 Tool Steel to S7 Tool Steel, and improve production readiness. |