ADIANA PERMANENT CONTRACEPTION SYSTEM
FDA premarket approval P070022/S004 · decided 2010-07-28
Approval details
- PMA number
- P070022
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADIANA PERMANENT CONTRACEPTION SYSTEM
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Hologic, Inc.
- Date received
- 2010-05-28
- Decision date
- 2010-07-28
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR CHANGING A CONTRAINDICATION IN THE ADIANA INSTRUCTION FOR USE TO REDUCE THE MINIMUM INTERVAL BETWEEN CONCLUSION OF A PREGNANCY AND THE ADIANA PROCEDURE FROM 12 WEEKS TO SIX WEEKS AND FOR ADDING A WARNING REGARDING INCOMPLETE UTERINE INVOLUTION.
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