PMA P030005S166
- Device
- Valitude, Valitude X4, Visionist, Visionist X4 (Accolade (CRT-Ps), Intua, Invive (Ingenio CRT-Ps)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S166
- Product code
- NKE
- Decision date
- 2017-12-01
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Upgrade device header overmolding equipment.
Current openFDA PMA Record#
- Device
- Valitude, Valitude X4, Visionist, Visionist X4 (Accolade (CRT-Ps), Intua, Invive (Ingenio CRT-Ps)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S166
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2017-12-01
- Decision code
- OK30
- Date received
- 2017-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Upgrade device header overmolding equipment.