LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
FDA premarket approval P910018/S019 · decided 2016-04-19
Approval details
- PMA number
- P910018
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2016-04-08
- Decision date
- 2016-04-19
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Implementation of a new manufacturing site for the vendor [Neat Co., Ltd.] of the GD cap component of the SULFLUX® KP-05 as part of the LIPOSORBER® LA-15 System.
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