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 | CELSIUS II BIDIRECTIONAL DEFLECTING DIAGNOSTIC/ABLATION CATHETER |
Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Regulation Number | 870.1220 |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S013 |
Date Received | 05/23/2001 |
Decision Date | 06/22/2001 |
Product Code |
DRF |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE BIDIRECTIONAL CATHETER TIP TO BE MODIFIED FROM A DUAL LUMEN TO A QUAD LUMEN. |
|
|