CHAMPION WRAP PTCA CATHETER
FDA premarket approval P930012/S010 · decided 1998-06-15
Approval details
- PMA number
- P930012
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CHAMPION WRAP PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Progressive Angioplasty Systems, Inc.
- Date received
- 1998-05-08
- Decision date
- 1998-06-15
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for 1) a change in trade names for the Champion(TM) HP PTCA Catheters and Champion(TM) HP PTCA Catheters with Wrap(TM) Sheathing System previously approved under PMA supplements 5, 8, and 9, and 2) a reduction in the wall thickness of the 3.5 mm and 4.0 mm diameter balloons used in these designs. the devices, as modified, will be marketed under the trde names Champion(TM) NC PTCA Catheter and Wrap(TM) NC PTCA Catheter, and are indicated for balloon dilatation of the stenotic portion of
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