|
Device | SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROOVE, MN 55311-1566 |
PMA Number | P840040 |
Supplement Number | S048 |
Date Received | 04/25/1995 |
Decision Date | 08/29/1995 |
Withdrawal Date
|
01/05/2007 |
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 APPROVAL FOR NEW PTCA CATHETER CREATED BY THE MODIFICATION OF THE SYNERGY II PTCA CATHETER MARKETED UNDER THE TRADE NAME:SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER |