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 changes in the instructions for use, the addition of a pump head with longer tubing, a change in the cleaning process, and the addition of stopcocks on the pumps
| Device | LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | LEOCOR, INC. |
| Date Received | 1994-09-01 |
| Decision Date | 1996-06-13 |
| PMA | P890001 |
| Supplement | S011 |
| 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 | LEOCOR, INC. 1301 Regents Pk. Dr. houston, TX 77058 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890001 | Original Filing | |
| S020 | 1996-11-29 | Normal 180 Day Track |
| S019 | 1996-10-03 | Normal 180 Day Track |
| S018 | 1996-09-09 | Normal 180 Day Track |
| S017 | ||
| S016 | 1996-04-18 | Normal 180 Day Track |
| S015 | 1995-12-01 | Normal 180 Day Track |
| S014 | 1995-06-21 | 30-Day Supplement |
| S013 | ||
| S012 | 1995-03-03 | 30-Day Supplement |
| S011 | 1994-09-01 | Normal 180 Day Track |
| S010 | 1993-10-07 | Normal 180 Day Track |
| S009 | 1993-09-16 | Normal 180 Day Track |
| S008 | ||
| S007 | 1991-12-23 | Normal 180 Day Track |
| S006 | 1991-09-27 | Normal 180 Day Track |
| S005 | 1991-05-14 | Normal 180 Day Track |
| S004 | 1990-10-15 | Normal 180 Day Track |
| S003 | 1990-02-14 | Normal 180 Day Track |
| S002 | 1990-05-17 | Panel Track |
| S001 | 1990-04-10 | Normal 180 Day Track |