Device Dossier
MINT Sterile single use absorbable polydioxanone suture with needle - Suture, polydioxanone
Device Dossier for MINT Sterile single use absorbable polydioxanone suture with needle - Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor…
- GMDN category: Suture, polydioxanone
Intended purpose
This device is intended to fixate sub dermal tissue in an elevated position in plastic and reconstructive surgery. The device is designed for minimally invasive face and neck application and is used in case of: - Slight and moderate skin laxity, soft tissue ptosis (without excessive skin volume) - Age-related neck changes, caused by atrophic processes of skin - Atrophic changes or uneven surface of skin and subdermal soft tissues
Functional description
Synthetic monofilament absorbable sterile surgical suture composed of Polydioxanone with needle. Strength is 65% after 4 weeks of original strength, and it takes 180 to 240 days for complete absorption. It complies with absorbable suture requirement of American pharmacopoeia.