PMA P030005S198
- Device
- CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S198
- Product code
- NKE
- Decision date
- 2020-08-03
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Automate parts of the final pack manufacturing process.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S198
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-08-03
- Decision code
- OK30
- Date received
- 2020-07-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automate parts of the final pack manufacturing process.