PMA P130012
- Device
- Myopore® Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S010
- Product code
- DTB
- Decision date
- 2024-04-19
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- to implement a cleaning method change for the Myopore Sutureless Myocardial Pacing Lead
Current openFDA PMA Record#
- Device
- Myopore® Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S016
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2024-04-19
- Decision code
- OK30
- Date received
- 2024-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a cleaning method change for the Myopore Sutureless Myocardial Pacing Lead