FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
FDA premarket approval P870076/S018 · decided 2016-03-22
Approval details
- PMA number
- P870076
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2015-12-08
- Decision date
- 2016-03-22
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Southborough, MA
- Statement
- Approval for a manufacturing site located at 9600 Louisiana Avenue North, Brooklyn Park, MN 55445 for the production of the Falope Ring Band.
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