FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Laparoscopic Contraceptive Tubal Occlusion Device
PMA: P070022
·
Supplement: S001
·
Decision Oct 20, 2009
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Laparoscopic Contraceptive Tubal Occlusion Device
- Trade Name
- ADIANA PERMANENT CONTRACEPTION SYSTEM
- PMA Number
- P070022
- Supplement Number
- S001
- 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
- October 20, 2009
- Date Received
- August 4, 2009
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR CHANGING THE ADIANA INSTRUCTIONS FOR USE TO MAKE USE OF THE SPLIT INTRODUCER OPTIONAL.
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 |