FALOPE-RING BAND & APPLICATOR SYSTEMS
FDA premarket approval P870076/S011 · decided 2010-07-08
Approval details
- PMA number
- P870076
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FALOPE-RING BAND & APPLICATOR SYSTEMS
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2010-06-15
- Decision date
- 2010-07-08
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Southborough, MA
- Statement
- CHANGE IN SUPPLIER OF THREE COMPONENTS OF THE DEVICE.
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