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: VISIONIST Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices
• Generic Name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
• Applicant: GUIDANT CORP.; 4100 HAMLINE AVENUE NORTH; ST. PAUL, MN 55112-5798
• PMA Number: P030005
• Supplement Number: S150
• Date Received: 01/30/2017
• Decision Date: 02/21/2017
• Product Code: NKE
• 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  
Implementation of the following previously accepted changes: (1) Changes to the molding manufacturing line; (2) Changes to an acceptance limit and sampling rate during battery testing; (3) Changes to visual inspection criteria for cosmetic defects; (4) Addition of a software interface between the traceability system software and the braze oven equipment for the feedthru component braze process; (5) Addition of an alternate sterilization cycle for pulse generators; (6) Additional supplier for the raw material used in low voltage battery lids; (7) Addition of an alternate supplier of titanium for pulse generator case halves; and (8) Additional manufacturing inspection step along with associated specification and inspection criteria that will allow pulse generator case half discontinuities to be distinguished from dents.