FDA Product Code PAW: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
To Repair Or Replace Chordae Tendinae.
Leading manufacturers include Chawla Heart Technologies, LLC.
FDA 510(k) Cleared Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement Devices (Product Code PAW)
About Product Code PAW - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PAW since 2012, with 3 receiving FDA clearance (average review time: 105 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PAW have taken an average of 150 days to reach a decision - up from 82 days historically. Manufacturers should account for longer review timelines in current project planning.
PAW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →