|
Device | SCHNEIDER CHUBBY(TM) PTCA CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | BOSTON SCIENTIFIC One Scimed Place Maple Grove, MN 55311 |
PMA Number | P880027 |
Supplement Number | S042 |
Date Received | 11/06/1996 |
Decision Date | 02/04/1997 |
Withdrawal Date
|
04/13/2007 |
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 ADDITIONAL BALLOON SIZES OF 4.5 AND 5.0 MM IN THE CHUBBY PTCA CATHETER LINE. |