LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED)
FDA premarket approval P890001/S014 · decided 1996-06-13
Approval details
- PMA number
- P890001
- Supplement
- S014
- Supplement type
- THIRTY DAY TRACK
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED)
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Leocor, Inc.
- Date received
- 1995-06-21
- Decision date
- 1996-06-13
- Days to decision
- 358 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR REVISED LABELING
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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 |