ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S048 · decided 2016-12-14
Approval details
- PMA number
- P020014
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2016-11-21
- Decision date
- 2016-12-14
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- Establishment of a new site for manufacturing the delivery wire (component of the Essure delivery system) at 340 Lake Hazeltine Drive, Chaska, Minnesota.
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