- Device
- AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S033
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2023-10-19
- Decision code
- OK30
- Date received
- 2023-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternate Tier III supplier for raw material used in the hydrophilic coating