FALOPE-RING CAND AND APPLICATOR SYSTEMS
FDA premarket approval P870076/S013 · decided 2012-10-26
Approval details
- PMA number
- P870076
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FALOPE-RING CAND AND APPLICATOR SYSTEMS
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2012-10-04
- Decision date
- 2012-10-26
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Southborough, MA
- Statement
- APPROVAL FOR LABELING CHANGES INCLUDING ADDING/ MODIFYING WARNINGS IN THE INSTRUCTION FOR USE, UPDATING COMPANY BRANDING, AND SEPARATING THE QUICK REFERENCE GUIDES FOR THE REUSABLE AND DISPOSABLE APPLICATORS.
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510(k) clearances by this applicant
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