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| Device | VISIONIST Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices |
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| Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
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| Applicant | Guidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112 |
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| PMA Number | P030005 |
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| Supplement Number | S150 |
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| Date Received | 01/30/2017 |
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| Decision Date | 02/21/2017 |
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| Product Code |
NKE |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | 30-Day Notice |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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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. |
