PMA P950029S052

Device
SYMPHONY SR 2250 & DR 2550/RHAPSODY SR 2210/DR 2510/2530 & REPLY SR/DR & ESPRIT SR/DR
Applicant
MicroPort CRM USA, Inc.
PMA number
P950029
Supplement
S052
Product code
NVZ
Decision date
2010-05-26
Generic name
Pulse generator, permanent, implantable
Approval order statement
CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING.

Current openFDA PMA Record#

Device
SYMPHONY SR 2250 & DR 2550/RHAPSODY SR 2210/DR 2510/2530 & REPLY SR/DR & ESPRIT SR/DR
Applicant
MicroPort CRM USA, Inc.
PMA number
P950029
Supplement
S052
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2010-05-26
Decision code
OK30
Date received
2010-04-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING.