|
Device | MEDTRONIC (R) CAPSURE (R) EPI PACING LEAD MODEL 4695 |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P950024 |
Supplement Number | S004 |
Date Received | 07/17/2001 |
Decision Date | 08/08/2001 |
Product Code |
DTB |
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 IN THE SUPPLIER OF POLYETHERURETHANE. |