PMA P070022S010
- Device
- Adiana Permanent Contraception System
- Applicant
- HOLOGIC, INC.
- PMA number
- P070022
- Supplement
- S010
- Decision date
- 2011-02-16
Current openFDA PMA Record
- Device
- ADIANA PERMANENT CONTRACEPTION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P070022
- Supplement
- S010
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2011-02-16
- Decision code
- OK30
- Date received
- 2011-01-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE WORK INSTRUCTIONS FOR THE FLUID FILLING PROCESS OF THE DAMPER SUBASSEMBLY.