ESSURE PERMANENT BIRTH CONTROL SYSTEM
FDA premarket approval P020014/S013 · decided 2006-09-19
Approval details
- PMA number
- P020014
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ESSURE PERMANENT BIRTH CONTROL SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2006-07-17
- Decision date
- 2006-09-19
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BOOKLET.
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