ESSURE SYSTEM
FDA premarket approval P020014/S009 · decided 2005-07-12
Approval details
- PMA number
- P020014
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2005-01-24
- Decision date
- 2005-07-12
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR MODIFICATION OF DEVICE LABELING TO INCLUDE 4- AND 5-YEAR EFFECTIVENESS RESULTS AND OTHER LABELING CHANGES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.