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.
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 a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
| Device | 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 |
| PMA | P930012 |
| Supplement | S010 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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 |