CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S017 · decided 2012-02-24
Approval details
- PMA number
- P020014
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2008-04-04
- Decision date
- 2012-02-24
- Days to decision
- 1421 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL TO MODIFY THE EXISTING RF ENERGY WARNING TO ADD AN ESSURE/ NOVASURE WARNING. ADDITIONALLY, THE PMA SUPPLEMENT INCLUDES APPROVAL OF A POST-APPROVAL STUDY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.