CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S010 · decided 2006-10-11
Approval details
- PMA number
- P020014
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2005-11-23
- Decision date
- 2006-10-11
- Days to decision
- 322 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR MODIFICATION OF THE ESSURE PHYSICIAN AND PATIENT LABELING TO INCLUDE INFORMATION ON THE RESULTS OF THE POSTAPPROVAL STUDY FOR NEWLY TRAINED PHYSICIANS.
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