CONCEPTUS ESSURE SYSTEM
FDA premarket approval P020014/S020 · decided 2008-09-11
Approval details
- PMA number
- P020014
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCEPTUS ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2008-07-23
- Decision date
- 2008-09-11
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR A MODIFICATION TO SPECIFICATIONS OF THE DRY FLOW INTRODUCER AND THE ADDITION OF A BACK-UP BOND IN THE DETACHMENT MECHANISM.
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