PROSORBA COLUMN
FDA premarket approval P850020/S015 · decided 2002-05-15
Approval details
- PMA number
- P850020
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROSORBA COLUMN
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Applicant
- Fresenius Hemocare, Inc.
- Date received
- 2002-04-15
- Decision date
- 2002-05-15
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- REDUCTION IN THE TIME OF THE REACTION STEP IN THE MANUFACTURING PROCESS AND A DECREASE IN THE AMOUNT OF CARBODIIMIDE USED IN THE PROCESS.
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