|
Device | Amplia MRI & Quad CRT-D's; Brava CRT-D & Quad CRT-D's; Compia MRI CRT-D & Quad CRT-D; Viva Quad S & XT CRT-D; Viva S CR |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S559 |
Date Received | 08/19/2016 |
Decision Date | 09/15/2016 |
Product Code |
NIK |
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 Elimination of an in-process pull test performed on the connector subassembly. |