Therakos Cellex Procedural Kit
FDA premarket approval P860003/S096 · decided 2017-10-06
Approval details
- PMA number
- P860003
- Supplement
- S096
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Therakos Cellex Procedural Kit
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2017-09-08
- Decision date
- 2017-10-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Manufacturing process change to the mold tool for the illumination plate in the CELLEX Procedural Kit.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.