FDA.reportPublic FDA data

PMA P130012S013

Device
Myopore® Sutureless Myocardial Pacing Lead
Applicant
Great Batch Medical
PMA number
P130012
Supplement
S013
Product code
DTB
Decision date
2023-02-07
Classification
Cardiovascular
Generic name
permanent pacemaker Electrode
Approval order statement
Approval for changes being effected (CBE) to include revisions and enhancements to the content in the Myopore lead Instructions for Use manual and packaging labeling.

Current openFDA PMA Record#

Device
Myopore® Sutureless Myocardial Pacing Lead
Applicant
Great Batch Medical
PMA number
P130012
Supplement
S013
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2023-02-07
Decision code
APPR
Date received
2023-01-26
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for changes being effected (CBE) to include revisions and enhancements to the content in the Myopore lead Instructions for Use manual and packaging labeling.