|
Device | VITATRON DA+ C & T SERIES IPGS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P990001 |
Supplement Number | S097 |
Date Received | 09/22/2011 |
Decision Date | 10/21/2011 |
Product Code |
NVZ |
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 UPGRADE THE SOFTWARE VERSION FROM 1.5.1 TO 1.5.2 ON A LASER WELDER AT A SUPPLIER. |