- Device
- AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter)
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S030
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2021-12-23
- Decision code
- APPR
- Date received
- 2021-03-08
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a pre-coating plasma treatment step.