PROSORBA COLUMN
FDA premarket approval P850020/S018 · decided 2003-05-30
Approval details
- PMA number
- P850020
- Supplement
- S018
- 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
- 2003-04-30
- Decision date
- 2003-05-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- CHANGES TO THE STERILIZATION LOAD CONFIGURATION AND LENGTH OF STERILIZATION CYCLE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.