CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S003 · decided 2003-04-11
Approval details
- PMA number
- P020014
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- 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
- 2003-03-13
- Decision date
- 2003-04-11
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR LABELING CHANGES TO ADDRESS THE DIFFICULTY/FAILURE TO DISENGAGE OR DETACH THE DELIVERY WIRE FROM THE ESSURE MICRO-INSERT AND LABELING CHANGES TO STRENGTHEN THE RECOMMENDATION REGARDING USE OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) PRIOR TO THE ESSURE PROCEDURE.
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