- Device
- LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES
- Applicant
- Progressive Angioplasty Systems, Inc.
- PMA number
- P930012
- Supplement
- S011
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1998-09-02
- Decision code
- APPR
- Date received
- 1998-08-03
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for modifications to the Y-adapter, packaging and labeling of the LaCrosse(TM) PTCA Catheter, Wrap(TM) PTCA Cathter, Champion(TM) NC PTCA Catheter and Wrap(TM) NC PTCA Catheter product lines.