GAMBRO PRISMAFLEX TPE 2000 SET
FDA premarket approval P830063/S007 · decided 2015-06-26
Approval details
- PMA number
- P830063
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GAMBRO PRISMAFLEX TPE 2000 SET
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2015-05-29
- Decision date
- 2015-06-26
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- CHANGE TO THE PYROGEN TEST METHOD (FROM RABBIT TEST TO KINETIC-CHROMOGENIC LAL TEST) USED FOR PRODUCT RELEASE OF PRISMAFLEX TPE 2000 SETS.
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