COOK CHORIONIC VILLUS SAMPLING SET
FDA premarket approval P900007/S001 · decided 1998-07-08
Approval details
- PMA number
- P900007
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- COOK CHORIONIC VILLUS SAMPLING SET
- Generic name
- Catheter, sampling, chorionic villus
- Applicant
- Cook Incorporated
- Date received
- 1998-01-15
- Decision date
- 1998-07-08
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LLX
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- Approval for removing the condition of approval regarding collection of individual outcome data from each CVS case.
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