Note: 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. |
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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 |
Regulation Number | 870.5100 |
Applicant | LEOCOR, INC. 1301 REGENTS PK. DR. HOUSTON, TX 77058 |
PMA Number | P890001 |
Supplement Number | S011 |
Date Received | 09/01/1994 |
Decision Date | 06/13/1996 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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 |
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