FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Laparoscopic Contraceptive Tubal Occlusion Device
PMA: P870076
·
Supplement: S018
·
Decision Mar 22, 2016
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Laparoscopic Contraceptive Tubal Occlusion Device
- Trade Name
- FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
- PMA Number
- P870076
- Supplement Number
- S018
- Device Class
- FDA Class 3
- Product Code
- KNH
- Generic Name
- Laparoscopic contraceptive tubal occlusion device
- Regulation Number
- 884.5380
- Medical Specialty
- Obstetrics/Gynecology
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 22, 2016
- Date Received
- December 8, 2015
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for a manufacturing site located at 9600 Louisiana Avenue North, Brooklyn Park, MN 55445 for the production of the Falope Ring Band.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNH | Laparoscopic Contraceptive Tubal Occlusion Device | FDA class 3 | Obstetrics/Gynecology |