PMA P030005S221
- Device
- VALITUDE™ CRT-P, VALITUDE X4 CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S221
- Product code
- NKE
- Decision date
- 2022-09-27
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Implement an automatic handling system for the helium leak test process.
Current openFDA PMA Record#
- Device
- VALITUDE™ CRT-P, VALITUDE X4 CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S221
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-09-27
- Decision code
- OK30
- Date received
- 2022-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an automatic handling system for the helium leak test process.