PMA P980035S733

Device
Adapta, Versa, Sensia IPG, Relia IPG
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S733
Product code
NVZ
Decision date
2022-11-18
Generic name
Pulse generator, permanent, implantable
Approval order statement
Implement an AI Vision System in the BPA lid removal process.

Current openFDA PMA Record#

Device
Adapta, Versa, Sensia IPG, Relia IPG
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S733
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2022-11-18
Decision code
OK30
Date received
2022-11-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement an AI Vision System in the BPA lid removal process.