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. |
|
Device | GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | ENDOLOGIX, INC. 11 STUDEBAKER IRVINE, CA 92618 |
PMA Number | P970052 |
Supplement Number | S002 |
Date Received | 11/19/1997 |
Decision Date | 05/19/1998 |
Withdrawal Date
|
03/30/2009 |
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 modifications to the Guardian(TM) Balloon Coronary Dilatation Catheter. |
|
|