ESSURE SYSTEM
FDA premarket approval P020014/S021 · decided 2008-11-07
Approval details
- PMA number
- P020014
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2008-09-11
- Decision date
- 2008-11-07
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR MINOR DESIGN CHANGES TO THE ESSURE SYSTEM, I.E., DIMENSIONAL SPECIFICATION OF THE DELIVERY WIRE HOLDER; CHANGE TO THE RELEASE BAND POSITIONING; AND A CHANGE TO THE HEAT SHRINK TUBING LENGTH.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.