PMA P030005S190
- Device
- Cardiac Resynchronization Therapy - Pacemaker (CRT-P)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S190
- Product code
- NKE
- Decision date
- 2019-10-29
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.
Current openFDA PMA Record#
- Device
- Cardiac Resynchronization Therapy - Pacemaker (CRT-P)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S190
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2019-10-29
- Decision code
- OK30
- Date received
- 2019-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.