FDA.reportPublic FDA data

Skin-port tissue expander

Definition
An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.
GUDID devices
2,276
Last updated
2026-06-05 06:05:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00650551006596INTEGRAPMT CORPORATION3610-638-2I-ST62026-05-27
00650551006022INTEGRAPMT CORPORATION3610-76-ST2026-05-18
00650551006039INTEGRAPMT CORPORATION3610-76-2-ST2026-05-18
00650551006046INTEGRAPMT CORPORATION3611-690-2-ST2026-05-18
00650551006060INTEGRAPMT CORPORATION3610-636-3-ST2026-05-18
00650551006077INTEGRAPMT CORPORATION3611-230-2-ST2026-05-18
00650551006084INTEGRAPMT CORPORATION3614-42-2-ST2026-05-18
00650551006176INTEGRAPMT CORPORATION3614-14-2-IR2026-05-18
00650551006237INTEGRAPMT CORPORATION3611-691-IR-ST2026-05-18
00650551006503INTEGRAPMT CORPORATION3611-577-2-IR2026-05-18
00650551006510INTEGRAPMT CORPORATION3611-581-2-IR2026-05-18
00650551005391INTEGRA®PMT CORPORATION3610ES-72-2I-ST2025-03-26
10081317032332MENTOR CPX4 PLUS Enhance, Smooth, Tall HeightMENTOR TEXAS L.P.SCPX15THE2025-03-26
00650551002154INTEGRA®PMT CORPORATION3611-204-2I-ST2025-03-19
00650551002161INTEGRA®PMT CORPORATION3612-04-I-1T2025-03-19
00650551002772INTEGRA®PMT CORPORATION3610-76-2I-ST2025-03-19
00650551002833INTEGRA®PMT CORPORATION3612-06R-IR-ST2025-03-19
00650551002963INTEGRA®PMT CORPORATION3612-61A-IR-ST72025-03-19
00650551003083INTEGRA®PMT CORPORATION3610-23-32025-03-19
00650551003090INTEGRA®PMT CORPORATION3611-674-32025-03-19
00650551003168INTEGRA®PMT CORPORATION3611ES-12-IR-ST2025-03-19
00650551003175INTEGRA®PMT CORPORATION3611ES-13-IR-ST2025-03-19
00650551003182INTEGRA®PMT CORPORATION3612ES-04R-IR-ST2025-03-19
00650551003205INTEGRA®PMT CORPORATION3610-579-22025-03-19
00650551003212INTEGRA®PMT CORPORATION3611-675-22025-03-19
00650551003243INTEGRA®PMT CORPORATION3611-232-2-RB2025-03-19
00650551003311INTEGRA®PMT CORPORATION3610-626-22025-03-19
00650551003328INTEGRA®PMT CORPORATION3610-627-22025-03-19
00650551003335INTEGRA®PMT CORPORATION3612ES-04R-I2025-03-19
00650551003410INTEGRA®PMT CORPORATION3611-676-22025-03-19
00650551003427INTEGRA®PMT CORPORATION3611-677-22025-03-19
00650551003434INTEGRA®PMT CORPORATION3612ES-16L-I2025-03-19
00650551003441INTEGRA®PMT CORPORATION3610-628-I2025-03-19
00650551003595INTEGRA®PMT CORPORATION3611-2842025-03-19
00650551003601INTEGRA®PMT CORPORATION3614-4622025-03-19
00650551003656INTEGRA®PMT CORPORATION3610-22I-MACRO2025-03-19
00650551003779INTEGRA®PMT CORPORATION3614-04-ST2025-03-19
00650551003786INTEGRA®PMT CORPORATION3614-57-ST2025-03-19
00650551003793INTEGRA®PMT CORPORATION3610-10-ST2025-03-19
00650551003809INTEGRA®PMT CORPORATION3614-14-ST2025-03-19
00650551003823INTEGRA®PMT CORPORATION3610ES-62I-MICRO2025-03-19
00650551003830INTEGRA®PMT CORPORATION3614ES-12I-MICRO2025-03-19
00650551003847INTEGRA®PMT CORPORATION3611-6802025-03-19
00650551003977INTEGRA®PMT CORPORATION3610-902025-03-19
00650551004059INTEGRA®PMT CORPORATION3610-6302025-03-19
00650551004066INTEGRA®PMT CORPORATION3610-631-22025-03-19
00650551004264INTEGRA®PMT CORPORATION3611-243-2I2025-03-19
00650551004295INTEGRA®PMT CORPORATION3610-58-2-ST2025-03-19
00650551004301INTEGRA®PMT CORPORATION3610-72-2-ST2025-03-19
00650551004318INTEGRA®PMT CORPORATION3614-5562025-03-19
00650551004370INTEGRA®PMT CORPORATION3610ES-46-I-ST2025-03-19
00650551004387INTEGRA®PMT CORPORATION3614ES-03-I-ST2025-03-19
00650551004394INTEGRA®PMT CORPORATION3614ES-12-I-ST2025-03-19
00650551004400INTEGRA®PMT CORPORATION3614ES-50-I-ST2025-03-19
00650551004554INTEGRA®PMT CORPORATION3611-6812025-03-19
00650551004561INTEGRA®PMT CORPORATION3611-682-22025-03-19
00650551004578INTEGRA®PMT CORPORATION3611-6832025-03-19
00650551004585INTEGRA®PMT CORPORATION3616ES-14-ST2025-03-19
00650551004660INTEGRA®PMT CORPORATION3611-6842025-03-19
00650551004684INTEGRA®PMT CORPORATION3610-632-2-ST2025-03-19
00650551004707INTEGRA®PMT CORPORATION3614-557-EP-ST2025-03-19
00650551004806INTEGRA®PMT CORPORATION3614ES-57I-ST2025-03-19
00650551005025INTEGRA®PMT CORPORATION3611-685-22025-03-19
00650551005056INTEGRA®PMT CORPORATION3611-582-22025-03-19
00650551005155INTEGRA®PMT CORPORATION3612ES-24-2IR-ST2025-03-19
00650551005162INTEGRA®PMT CORPORATION3614-215I-ST2025-03-19
00650551005179INTEGRA®PMT CORPORATION3614-60-2I-ST2025-03-19
00650551005186INTEGRA®PMT CORPORATION3610-62-2I-ST2025-03-19
00650551005193INTEGRA®PMT CORPORATION3610-60-2I-ST2025-03-19
00650551005209INTEGRA®PMT CORPORATION3610-62I-ST2025-03-19
00650551005216INTEGRA®PMT CORPORATION3611-37-2I-ST2025-03-19
00650551005247INTEGRA®PMT CORPORATION3614ES-57I-MICRO2025-03-19
00650551005261INTEGRA®PMT CORPORATION3611-686-22025-03-19
00650551005384INTEGRA®PMT CORPORATION3610-618-22025-03-19
00650551096269INTEGRA®PMT CORPORATION3610-603-2I-ST2025-03-19
00650551096382INTEGRA®PMT CORPORATION3614ES-57-IR2025-03-19
00650551097891INTEGRA®PMT CORPORATION3611ES-577-2I2025-03-19
00650551097921INTEGRA®PMT CORPORATION3611ES-582-2I2025-03-19
00650551097938INTEGRA®PMT CORPORATION3611ES-582-2I-ST2025-03-19
00650551097945INTEGRA®PMT CORPORATION3611ES-577-2I-ST2025-03-19