PMA P070022S004
- Device
- Adiana Permanent Contraception System
- Applicant
- HOLOGIC, INC.
- PMA number
- P070022
- Supplement
- S004
- Decision date
- 2010-07-28
Current openFDA PMA Record
- Device
- ADIANA PERMANENT CONTRACEPTION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P070022
- Supplement
- S004
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2010-07-28
- Decision code
- APPR
- Date received
- 2010-05-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.