CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S027 · decided 2009-06-19
Approval details
- PMA number
- P020014
- Supplement
- S027
- Supplement type
- Special (Immediate 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
- 2009-05-22
- Decision date
- 2009-06-19
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR CHANGES TO THE PHYSICIAN LABELING REGARDING PERFORATION AND HYPERVOLEMIA.
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