PMA P050018S024
- Device
- AngioSculpt RX PTCA Scoring Balloon Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S024
- Product code
- NWX
- Decision date
- 2017-04-17
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- Change to the biological indicator utilized to build the internal process challenge device.
Current openFDA PMA Record#
- Device
- AngioSculpt RX PTCA Scoring Balloon Catheter
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S024
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2017-04-17
- Decision code
- OK30
- Date received
- 2017-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the biological indicator utilized to build the internal process challenge device.