Product Classification

• Device: scaffold, infrapopliteal, absorbable
• Definition: The absorbable scaffold is for improving luminal diameter for the treatment of lesions in native infrapopliteal arteries.
• Physical State: Absorbable stent or scaffold and delivery catheter
• Technical Method: Absorbable stent or scaffold placed via a delivery catheter into the native infrapopliteal arteries
• Target Area: native infrapopliteal arteries
• Review Panel: Cardiovascular
• Product Code: NXW
• Premarket Review: Office of Cardiovascular Devices (OHT2); Coronary and Peripheral Interventional Devices (DHT2C)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 3-193 ISO 12417-1 Second edition 2024-02
  Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
• 3-197 ISO 25539-4 First edition 2021-11
  Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices

Third Party Review

Not Third Party Eligible