Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Basic Information
- Device Name
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- Trade Name
- VISIONIST Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices
- PMA Number
- P030005
- Supplement Number
- S150
- Device Class
- FDA Class 3
- Product Code
- NKE
- Generic Name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 21, 2017
- Date Received
- January 30, 2017
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | FDA class 3 | Unknown |