COOK CHORIONIC VILLUS SAMPLING SET
FDA premarket approval P900007/S005 · decided 2009-04-02
Approval details
- PMA number
- P900007
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COOK CHORIONIC VILLUS SAMPLING SET
- Generic name
- Catheter, sampling, chorionic villus
- Applicant
- Cook Incorporated
- Date received
- 2008-11-17
- Decision date
- 2009-04-02
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LLX
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR THE ADDITION OF ECHOTIP BANDING TO THE DISTAL TWO CENTIMETERS OF THE OBTURATOR.
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