Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: ACUITY X4 E24 Molding NOR Optimization
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: Boston Scientific Corp; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P010012
• Supplement Number: S496
• Date Received: 01/30/2019
• Decision Date: 02/04/2019
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
New normal operating range for molding temperature and cure time during the molding process.