CONCEPTUS ESSURE SYSTEM
FDA premarket approval P020014/S037 · decided 2012-05-17
Approval details
- PMA number
- P020014
- Supplement
- S037
- Supplement type
- 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
- 2012-03-05
- Decision date
- 2012-05-17
- Days to decision
- 73 days
- Decision code
- OK30
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- REPLACE THE CURRENT MANUAL DEPLOY AND DETACH TEST FIXTURE WITH AN AUTOMATED TEST FIXTURE FOR LOT RELEASE TESTING OF HE ESSURE SYSTEM.
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