GAMBRO PRISMAFLEX TPE 2000 SET
FDA premarket approval P830063/S008 · decided 2015-11-12
Approval details
- PMA number
- P830063
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2015-10-13
- Decision date
- 2015-11-12
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- APPROVAL FOR A LABELING CHANGE TO ADDRESS COMPLAINTS RELATED TO LUER CONNECTOR CRACKS.
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