PMA P980035S178

Device
ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S178
Product code
NVZ
Decision date
2010-07-28
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER.

Current openFDA PMA Record#

Device
ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S178
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2010-07-28
Decision code
OK30
Date received
2010-06-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER.