UVAR XTS(TM) PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S037 · decided 2001-01-05
Approval details
- PMA number
- P860003
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UVAR XTS(TM) PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2000-07-07
- Decision date
- 2001-01-05
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR THE FOLLOWING SOFTWARE CHANGES: 1) REMOVAL OF SYSTEM ERROR F522:0000, 2) REMOVAL OF SYSTEM ERROR F581:0000, 3) CHANGE IN THE ALARM THRESHOLD FOR THE CENTRIFUGE BOWL VACUUM, AND 4) ADDITION OF NEW PRIMING STATE.
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