PMA P050018S011
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S011
- Product code
- NWX
- Decision date
- 2010-12-29
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- CHANGE TO INCREASE THE LOAD DENSITY FOR ETHYLENE OXIDE STERILIZATION OF THE ABOVE-STATED DEVICE.
Current openFDA PMA Record#
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S011
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2010-12-29
- Decision code
- OK30
- Date received
- 2010-10-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO INCREASE THE LOAD DENSITY FOR ETHYLENE OXIDE STERILIZATION OF THE ABOVE-STATED DEVICE.