PMA P070022S005
- Device
- ADIANA PERMANENT CONTRACEPTION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P070022
- Supplement
- S005
- Product code
- KNH
- Decision date
- 2010-07-21
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- ADDITION OF INCOMING INSPECTION REQUIREMENTS TO THE PLASTIC TUBING USED IN THE MATRIX MOLDING PROCESS.
Current openFDA PMA Record
- Device
- ADIANA PERMANENT CONTRACEPTION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P070022
- Supplement
- S005
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2010-07-21
- Decision code
- OK30
- Date received
- 2010-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF INCOMING INSPECTION REQUIREMENTS TO THE PLASTIC TUBING USED IN THE MATRIX MOLDING PROCESS.