ESSURE SYSTEM
FDA premarket approval P020014/S015 · decided 2008-06-10
Approval details
- PMA number
- P020014
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2008-02-04
- Decision date
- 2008-06-10
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR LABELING CHANGES REGARDING CONCOMITANT ESSURE AND ENDOMETRIAL ABLATION PROCEDURES.
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