LIPOSORBER LA-15 SYSTEM
FDA premarket approval P910018/S007 · decided 2003-03-06
Approval details
- PMA number
- P910018
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- LIPOSORBER LA-15 SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2000-08-22
- Decision date
- 2003-03-06
- Days to decision
- 926 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR THE TRANSFER OF THE ASSEMBLY AND SOLDERING OF PRINTED CIRCUIT BOARDS USED IN CONJUNCTION WITH THE FINAL ASSEMBLY OF THE MA-01 APHERESIS MACHINE TO YOKOGAWA IBIDEN COMPONENTS CORPORAITON, OUME-CITY, TOKYO 198 JAPAN.
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