CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S034 · decided 2011-07-01
Approval details
- PMA number
- P020014
- Supplement
- S034
- Trade name
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2011-04-12
- Decision date
- 2011-07-01
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL TO REMOVE A CONTRAINDICATION AND TO REVISE A WARNING REGARDING NICKEL SENSITIVITY IN PHYSICIANS LABELING.
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