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 PICO RUNNER(TM) PTCA CATHETER |
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 | S015 |
Date Received | 12/01/1995 |
Decision Date | 06/07/1996 |
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 AN EXTENSION OF THE LEOCOR PICO RUNNER PTCA CATHETER LINE TO INCLUDE A 4.0MM BALLOON DIAMETER |
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