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510(k) Data Aggregation
K Number
K102806Device Name
NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS
Manufacturer
ALLERGAN MEDICAL
Date Cleared
2011-01-05
(99 days)
Product Code
LCJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ALLERGAN MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NATRELLE® Tissue Expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expanders are intended for temporary subcutaneous implantation and are not intended for use beyond six months.
Device Description
Allergan's Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, three suture tabs, a MAGNA-SITE® integrated injection site (incorporating a titanium needle guard), and a stable, reinforced base to enable outward expansion. The three suture tabs are attached to the posterior surface of the shell at approximately the 12 o'clock, 4 o'clock, and 8 o'clock positions of the tissue expander. The Tissue Expanders are available in seven styles and each style consists of six sizes for a total of 42 products, to meet diverse surgical needs. The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. All injection sites contain a self-sealing port and a titanium needle guard to prevent inadvertent puncture through the base of the injection site.
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