Therakos CELLEX Procedural Kit
FDA premarket approval P860003/S100 · decided 2019-01-10
Approval details
- PMA number
- P860003
- Supplement
- S100
- 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
- 2018-12-13
- Decision date
- 2019-01-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Change in the manufacturing process for the CELLEX Procedural Kits' drive tube assemblies so that the same manufacturing steps used at the approved Mack Molding manufacturing site can also be used at the approved Harmac Medical, Buffalo, New York site.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.