EXTENSION TO THE PAS LACROSSE PTCA CATHETER PRODUCT LINE
FDA premarket approval P930012/S002 · decided 1996-04-16
Approval details
- PMA number
- P930012
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXTENSION TO THE PAS LACROSSE PTCA CATHETER PRODUCT LINE
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Progressive Angioplasty Systems, Inc.
- Date received
- 1995-10-04
- Decision date
- 1996-04-16
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- ADDITION OF 1.5MM DIAMETER, 20 MM LENGTH BALLOON; ADDITION OF 2.5MM, 3.0MM, AND 4.0MM BALLOONS, ALL WITH 30MM LENGTH; CHANGE IN RATED BURST OF THE 2.0MM AND 2.5MM BALLOONS WITH 20MM LENGTH
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