Therakos CELLEX Procedural Kit
FDA premarket approval P860003/S099 · decided 2018-11-01
Approval details
- PMA number
- P860003
- Supplement
- S099
- 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
- 2018-10-01
- Decision date
- 2018-11-01
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Change in the device's manufacturing validation implementing the use of an automated inspection fixture that will inspect the integrity of 100% of all THERAKOS® CELLEX® Procedural Kit Centrifuge Outer Bowl welds.
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