This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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
| Device | 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 |
| PMA | P930012 |
| Supplement | S002 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PROGRESSIVE ANGIOPLASTY SYSTEMS, INC. 1350 Willow Rd. Suite 201 menlo Park, CA 94025 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930012 | Original Filing | |
| S012 | 1998-07-24 | Normal 180 Day Track |
| S011 | 1998-08-03 | Real-time Process |
| S010 | 1998-05-08 | Real-time Process |
| S009 | 1998-01-08 | Real-time Process |
| S008 | 1997-08-19 | Normal 180 Day Track |
| S007 | ||
| S006 | 1997-03-06 | Normal 180 Day Track |
| S005 | 1996-08-01 | Normal 180 Day Track |
| S004 | 1996-06-27 | Normal 180 Day Track |
| S003 | 1995-11-13 | Normal 180 Day Track |
| S002 | 1995-10-04 | Normal 180 Day Track |
| S001 | 1995-10-04 | Normal 180 Day Track |