COOK CHORIONIC VILLUS SAMPLING SET
FDA premarket approval P900007/S006 · decided 2009-03-05
Approval details
- PMA number
- P900007
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COOK CHORIONIC VILLUS SAMPLING SET
- Generic name
- Catheter, sampling, chorionic villus
- Applicant
- Cook Incorporated
- Date received
- 2008-12-02
- Decision date
- 2009-03-05
- Days to decision
- 93 days
- Decision code
- OK30
- Product code
- LLX
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- MODIFICATION TO THE OBTURATOR HANDLE AND THE TECHNIQUE FOR AFFIXING IT TO THE OBTURATOR WIRE.
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