ADIANA PERMANENT CONTRACEPTION SYSTEM
FDA premarket approval P070022/S014 · decided 2011-09-06
Approval details
- PMA number
- P070022
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADIANA PERMANENT CONTRACEPTION SYSTEM
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Hologic, Inc.
- Date received
- 2011-02-28
- Decision date
- 2011-09-06
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR MINOR CHANGES TO THE SUGAR MOLD MANUFACTURING PROCESS.
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