CHAMPION WRAP PTCA CATHETER
FDA premarket approval P930012/S008 · decided 1998-02-02
Approval details
- PMA number
- P930012
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- 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
- 1997-08-19
- Decision date
- 1998-02-02
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for: 1) a line of Champion(TM) HP PTCA Catheters packaged with the Wrap(TM) Sheathing System; 2) the additionof quarter-sized balloons to this line of catheters extending the balloon diameter limits from 3.0-4.0 mm to 2.5-4.5mm; and 3) a revised package insert which streamlines the Instructions for Use and compresses the previous package inserts for the 15 mm and 20 mm long balloons into one combined insert.
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