THERAKOS CELLEX PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S058 · decided 2011-04-21
Approval details
- PMA number
- P860003
- Supplement
- S058
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2011-03-08
- Decision date
- 2011-04-21
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR AN ADDITIONAL STERILIZATION SITE LOCATED AT STERIGENICS US LLC IN CHARLOTTE, NORTH CAROLINA.
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