|
Device | Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S569 |
Date Received | 04/24/2023 |
Decision Date | 05/01/2023 |
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 Add a new Controlled Environment Area (CEA) Level VIII and a new CEA Level IX for pulse generator and implantable cardiac monitor battery manufacturing. |