- Device
- AngioSculpt PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S028
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2020-09-21
- Decision code
- OK30
- Date received
- 2020-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Material change at a supplier.