CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S025 · decided 2009-06-11
Approval details
- PMA number
- P020014
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2009-05-11
- Decision date
- 2009-06-11
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- CHANGE TO THE MANUFACTURING OF THE MECHANISM THAT HOLDS THE INNER CATHETER SUBASSEMBLY RELEASE RIBBON IN PLACE.
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