PMA P980035S482

Device
ADAPTA, VERSA, SENSIA IPG
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S482
Product code
NVZ
Decision date
2016-12-14
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
Implementation of an update to FACTORYworks (FW) Release 9.3.

Current openFDA PMA Record#

Device
ADAPTA, VERSA, SENSIA IPG
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S482
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2016-12-14
Decision code
OK30
Date received
2016-11-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an update to FACTORYworks (FW) Release 9.3.