DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
FDA premarket approval P870076/S012 · decided 2012-07-05
Approval details
- PMA number
- P870076
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2012-06-05
- Decision date
- 2012-07-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Southborough, MA
- Statement
- CHANGE IN THE QUALITY CONTROL METHOD USED DURING THE TRAY AND POUCH MANUFACTURING PROCESS.
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