PMA P050018S012
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S012
- Product code
- NWX
- Decision date
- 2011-03-30
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN SALT LAKE CITY, UTAH.
Current openFDA PMA Record#
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S012
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2011-03-30
- Decision code
- APPR
- Date received
- 2010-12-02
- 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 IN SALT LAKE CITY, UTAH.