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Device | INCEPTA,ENERGEN,PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATORS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S348 |
Date Received | 03/14/2014 |
Decision Date | 03/31/2014 |
Product Code |
LWP |
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 ALTERNATE PROCESS FOR EXCISING THE PRINTED CIRCUIT BOARDS (PCB) FROM THE PCB PANEL USING A LASER EXCISE SYSTEM. |