Essure System for Permanent Birth Control
FDA premarket approval P020014/S049 · decided 2017-12-04
Approval details
- PMA number
- P020014
- Supplement
- S049
- 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
- 2017-11-20
- Decision date
- 2017-12-04
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- Change in a supplier's site of manufacture of the wound coil, inner coil and outer coil critical components from Tualatin Oregon to Heredia, Costa Rica.
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