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 | NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP 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 | P990025 |
Supplement Number | S003 |
Date Received | 12/21/2000 |
Decision Date | 01/11/2001 |
Product Code |
DRF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE POLYMERIC MIXTURE USED TO MANUFACTURE THE CATHETER'S TIP. THE CHANGE IS INTENDED TO STANDARDIZE PROCESSES ACROSS THE NAVI-STAR PRODUCT LINE. |
|
|