|
Device | MEDTRONIC KAPPA 700/600 PULSE GENERATOR |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S010 |
Date Received | 04/13/2001 |
Decision Date | 05/14/2001 |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE EPOXY APPLICATION PATTERN AND A WIRE BOND LOOP PROGRAM IN THE ABOVE REFERENCED FAMILY OF PULSE GENERATORS. |