CHAMPION WRAP PTCA CATHETER
FDA premarket approval P930012/S009 · decided 1998-02-23
Approval details
- PMA number
- P930012
- Supplement
- S009
- 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
- 1998-01-08
- Decision date
- 1998-02-23
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for the addition of (1) quarter-size diameter balloons, including sizes of 2.5 mm, 2.75 mm, 3.25 mm, 3.75 mm, 4.25 mm, and 4.5 mm, and (2) a second radiopaque marker to all 20 mm long balloon catheters. The referenced devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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