ESSURE SYSTEM
FDA premarket approval P020014/S008 · decided 2005-01-31
Approval details
- PMA number
- P020014
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2004-09-20
- Decision date
- 2005-01-31
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR A PROPOSED PACKAGING MODIFICATION AND SUBSEQUENT CHANGES TO THE ETHYLENE OXIDE (EO) STERILIZATION CYCLE AND SHELF LIFE VALIDATION STUDY.
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