PMA P860003S058
- Device
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S058
- Product code
- LNR
- Decision date
- 2011-04-21
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR AN ADDITIONAL STERILIZATION SITE LOCATED AT STERIGENICS US LLC IN CHARLOTTE, NORTH CAROLINA.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S058
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2011-04-21
- Decision code
- APPR
- Date received
- 2011-03-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL STERILIZATION SITE LOCATED AT STERIGENICS US LLC IN CHARLOTTE, NORTH CAROLINA.