PMA P050018S036
- Device
- AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S036
- Product code
- NWX
- Decision date
- 2025-01-15
- Classification
- Cardiovascular
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- a new raw material supplier for the hypotube
Current openFDA PMA Record#
- Device
- AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S036
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2025-01-15
- Decision code
- OK30
- Date received
- 2024-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new raw material supplier for the hypotube