PMA P950020S079
- Device
- WOLVERINE CORONARY CUTTING BALLOON (MONORAIL AND OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S079
- Product code
- NWX
- Decision date
- 2017-02-09
- 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 Boston Scientific Corporation, Two Scimed Place, Maple Grove, Minnesota, for the ZGlide manufacturing process and application.
Current openFDA PMA Record#
- Device
- WOLVERINE CORONARY CUTTING BALLOON (MONORAIL AND OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S079
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2017-02-09
- Decision code
- APPR
- Date received
- 2016-11-30
- 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 Boston Scientific Corporation, Two Scimed Place, Maple Grove, Minnesota, for the ZGlide manufacturing process and application.