THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS
FDA premarket approval P860003/S064 · decided 2012-04-04
Approval details
- PMA number
- P860003
- Supplement
- S064
- Supplement type
- Special (Immediate Track)
- Trade name
- THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2012-01-24
- Decision date
- 2012-04-04
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR LABELING CHANGES TO ENSURE THE APPROPRIATE DOSING OF HEPARIN FOR LOW BODY WEIGHT PATIENTS.
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