LEOCOR SABLE(TM) PTCA CATHETER
FDA premarket approval P890001/S018 · decided 1997-06-11
Approval details
- PMA number
- P890001
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LEOCOR SABLE(TM) PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Leocor, Inc.
- Date received
- 1996-09-09
- Decision date
- 1997-06-11
- Days to decision
- 275 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR A NEW MODEL PTCA CATHETER, THE SABLE(TM) PTCA CATHETER. THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEOCOR CORFLO PUMP -- MODIFICATION (K924110) | Leocor, Inc. | 1992-09-01 |
| LEOCOR GUIDING CATHETER (K911270) | Leocor, Inc. | 1992-01-17 |
| LEOCOR CORFLO(TM) PUMP (K900350) | Leocor, Inc. | 1990-07-17 |