FDA.reportPublic FDA data

PMA P030005S201

Device
VALITUDE, VALITUDE X4, VISIONIST, and VISIONIST X4 CRT-P Devices
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S201
Product code
NKE
Decision date
2020-10-16
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement
Approval to allow an additional mold release/de-nest agent to be applied to the polyethylene terephthalate glycol (PETG) sheets used to form sterile packaging.

Current openFDA PMA Record#

Device
VALITUDE, VALITUDE X4, VISIONIST, and VISIONIST X4 CRT-P Devices
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S201
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date
2020-10-16
Decision code
APPR
Date received
2020-08-13
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to allow an additional mold release/de-nest agent to be applied to the polyethylene terephthalate glycol (PETG) sheets used to form sterile packaging.