CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S004 · decided 2003-07-17
Approval details
- PMA number
- P020014
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2003-05-21
- Decision date
- 2003-07-17
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR NEW EXPIRATION DATES FOR THE GAMMA CATHETER (WITH PACKAGING PROCESS IMPROVEMENTS) AND THE COIL CATHETER (WITH PACKAGING PROCESS IMPROVEMEMENTS.)
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