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 | BONNIE (TM) PTCA CATHERS |
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 | S051 |
Date Received | 08/13/1997 |
Decision Date | 10/23/1997 |
Withdrawal Date
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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 Approval for 30 and 40 mm length models of the Bonnie(TM) PTCA Catheter. The new models will be marketed under the trade name Bonnie(TM) Monorail(R) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters and are indicated for balloon dilatation for the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
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