Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Basic Information
- Device Name
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- Trade Name
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- PMA Number
- P040046
- Supplement Number
- S009
- Device Class
- FDA Class 3
- Product Code
- FTR
- Generic Name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Regulation Number
- 878.3540
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 13, 2015
- Date Received
- September 15, 2014
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE FOLLOWING PACKAGING AND MANUFACTURING CHANGES:1) MODIFICATION OF THE PRIMARY INNER AND OUTER TRAY PACKAGING TO INCLUDE TWO FINGER TABS;2) MODIFICATION OF THE OUTER TRAY TO INCLUDE TWO CAVITIES;3) A CHANGE OF THE POLYCARBONATE TRAY MATERIAL TO GEOX PEEREX® 51 PC POLYCARBONATE FILM TO BE SUPPLIED BY PRENT THERMOFORMING;4) PRIMARY LID PACKAGING THAT IS LARGER WITH BLUE INK ARROWS; 5) LARGER SECONDARY PACKAGING BOXES TO HOUSE THE LARGER TRAYS;6) A CHANGE TO A SEPARATE TAMPER EVIDENT LABEL, I.E., THE PRODUCT LABELS NO LONGER SERVE AS A TAMPER EVIDENT LABEL; AND7) CHANGES TO THE HEAT SEALING PROCESS (NEW PARAMETERS: TEMPERATURE = 236-256 DEGREE F, DWELL TIME = 4.9-6.9 S, PRESSURE = 60-80 PSI).
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 |
|---|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FDA class 3 | General, Plastic Surgery |