ACMI FALOPE RING BAND
FDA premarket approval P870076/S008 · decided 2007-05-24
Approval details
- PMA number
- P870076
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACMI FALOPE RING BAND
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2006-08-18
- Decision date
- 2007-05-24
- Days to decision
- 279 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 GYRUS ACMI CORPORATION, MAPLE GROVE MINNESOTA TO MANUFACTURE THE FALOPE RING BAND AND THE FALOPE RING BAND DISPOSABLE APPLICATOR KITS.
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