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.
| Device | LEOCOR,INC. PICOCATH CATHETER 2,2.5,3,3.5, BALLOON |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | LEOCOR, INC. |
| Date Received | 1990-02-14 |
| Decision Date | 1991-03-08 |
| PMA | P890001 |
| Supplement | S003 |
| 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 |