|
Device | CAPSUREFIX LEAD; CAPSUREFIX NOVIS LEAD, SUREFIX LEAD |
Generic Name | Permanent defibrillator electrodes |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P930039 |
Supplement Number | S104 |
Date Received | 01/29/2014 |
Decision Date | 02/27/2014 |
Product Code |
NVY |
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 REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS. |