- Device
- AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S034
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2024-02-14
- Decision code
- APPR
- Date received
- 2023-11-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site located at Creganna Medical S.L.R, San Rafael, Costa Rica to manufacture the base catheter