ADIANA PERMANENT CONTRACEPTION SYSTEM
FDA premarket approval P070022/S009 · decided 2010-12-21
Approval details
- PMA number
- P070022
- Supplement
- S009
- Supplement type
- 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
- 2010-11-23
- Decision date
- 2010-12-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- NEW MANUFACTURING LINE AND THE ADDITION OF MANUFACTURING EQUIPMENT.
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