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.
Modified device packaging for all leocor's currently marketed ptca catheters.
| Device | LEOCOR SABLE(TM) PTCA CATHETER |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | LEOCOR, INC. |
| Date Received | 1996-11-29 |
| Decision Date | 1997-01-16 |
| PMA | P890001 |
| Supplement | S020 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |