|
Device | ASTRA S DR MRI IPG/ ASTRA S SR MRI IPG / ASTRA XT DR MRI IPG / ASTRA XT SR MRI IPG |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S515 |
Date Received | 07/20/2017 |
Decision Date | 08/17/2017 |
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 Changes to a manufacturing visual inspection specification used for hybrid production. |