CONCEPTUS ESSURE SYSTEM
FDA premarket approval P020014/S024 · decided 2009-08-26
Approval details
- PMA number
- P020014
- Supplement
- S024
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCEPTUS ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2009-01-30
- Decision date
- 2009-08-26
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE WOUND INNER/OUTER COIL (PRECISION WIRE COMPONENTS) OF THE DEVICE.
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