PMA P040046S009
- Device
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S009
- Product code
- FTR
- Decision date
- 2015-03-13
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order 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).
Current openFDA PMA Record#
- Device
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S009
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2015-03-13
- Decision code
- APPR
- Date received
- 2014-09-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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).