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U.S. Department of Health and Human Services

Product Classification

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Device carbon dioxide gas controlled tissue expander
Definition A carbon dioxide gas controlled tissue expander is intended for tissue expansion.
Physical State It includes an inflatable elastomer shell with an implanted canister containing compressed carbon dioxide. It includes a remote controller that communicates with the implanted tissue expander to release carbon dioxide from the implanted canister into the shell.
Technical Method A carbon dioxide gas controlled tissue expander is made of an inflatable elastomer shell and is filled with carbon dioxide gas. It utilizes a remote controller to administer doses of carbon dioxide gas from an implanted canister inside the tissue expander.
Target Area Breasts, soft tissue
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePQN
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch One - Implants and Tools (PRSB1)
Submission Type 510(k)
Regulation Number 878.3510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible