PMA P030005S151
- Device
- VALITUDE Models: U125, U128; VISIONIST Models: U225, U226, U228
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S151
- Product code
- NKE
- Decision date
- 2017-03-29
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Change to the method of cleaning a soldering iron tip; 2) changes to the cleaning process of the trays; 3) modification of the solder fixture; and 4) changes to the cleaning of the solder fixture.
Current openFDA PMA Record#
- Device
- VALITUDE Models: U125, U128; VISIONIST Models: U225, U226, U228
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S151
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2017-03-29
- Decision code
- OK30
- Date received
- 2017-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the method of cleaning a soldering iron tip; 2) changes to the cleaning process of the trays; 3) modification of the solder fixture; and 4) changes to the cleaning of the solder fixture.