PMA P050018S004
- Device
- ANGIOSCULPT SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S004
- Product code
- NWX
- Decision date
- 2008-04-23
- 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 AT STERIGENICS, INC., LOS ANGELES, CALIFORNIA AS AN ALTERNATE CONTRACT STERILIZATION FACILITY.
Current openFDA PMA Record#
- Device
- ANGIOSCULPT SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S004
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2008-04-23
- Decision code
- APPR
- Date received
- 2008-03-12
- 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 AT STERIGENICS, INC., LOS ANGELES, CALIFORNIA AS AN ALTERNATE CONTRACT STERILIZATION FACILITY.