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 SABLE(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 | S020 |
Date Received | 11/29/1996 |
Decision Date | 01/16/1997 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFIED DEVICE PACKAGING FOR ALL LEOCOR'S CURRENTLY MARKETED PTCA CATHETERS. |
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