THERAPEUTIC APHERESIS SYSTEM

FDA Premarket Approval P850092

Pre-market Approval Supplement Details

• Device: THERAPEUTIC APHERESIS SYSTEM
• Generic Name: Separator, Automated, Blood Cell And Plasma, Therapeutic
• Applicant: MILLIPORE CORP.
• Date Received: 1985-12-18
• Decision Date: 1986-11-18
• Notice Date: 1986-12-24
• PMA: P850092
• Supplement: S
• Product Code: LKN
• Docket Number: 86M-0481
• Advisory Committee: Gastroenterology/Urology
• Expedited Review: No
• Combination Product: No
• Applicant Address: MILLIPORE CORP. 80 Ashby Rd. p.o. Box 9125 bedford, MA 01730

Supplemental Filings

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Supplement Number	Date	Supplement Type
P850092		Original Filing