GC Aesthetics® Instruction For Use (IFU) and Patient Consent Form (PCF)
How to get your IFU and Patient Consent Form?
Make sure your browser can open PDFs or download Adobe Acrobat Reader (free PDF Reader software). https://get.adobe.com/reader/
Check on the product Label: - The Product Name - The Product Lot Number This information will allow you to find the IFU and Patient Consent Form corresponding to your product.
Find the IFU and Patient Consent Form applicable to your product in the correspondence table and check the latest version in force.
Blossom™ IVTE
Blossom™ IVTE, is the Integrated Valve Tissue Expander by GC Aesthetics®. The product is intended for temporary subcutaneous implantation and requires periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
Renuvé™ RVTE
Renuvé™ RVTE tissue expanders feature a universal self-sealing 28 mm injection port with an internal needle-stop and reinforced base, keeping puncture risk low and shell integrity high (exceeding ISO standards). Radiopaque tubing and a stainless-steel, length-adjustable connector simplify placement, while the smooth-surface expanders come sterile in five shapes—Round, Rectangular, Straight or Curved Cylindrical, and Croissant—covering 200 cc-1,100 cc volumes for face or body use.
Disclaimer
The information presented here is not intended or implied to be a substitute for professional medical advice, diagnosis, or treatment. All content and information contained on or available through this website is for general information purposes only. You are encouraged to confirm any information obtained from or through this content with other sources and review all information regarding any medical condition or treatment with your physician.