ESSURE SYSTEM
FDA premarket approval P020014/S001 · decided 2003-03-06
Approval details
- PMA number
- P020014
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2002-12-23
- Decision date
- 2003-03-06
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR A MODIFIED DELIVERY CATHETER CALLED THE COIL CATHETER AND A MODIFIED SPLIT INTRODUCER.
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