Essure System for Permanent Birth Control
FDA premarket approval P020014/S050 · decided 2018-03-22
Approval details
- PMA number
- P020014
- Supplement
- S050
- 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
- 2018-03-01
- Decision date
- 2018-03-22
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- Increase of the production lot quantity of ESS305 to a full production lot size of 468 kits.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.