PMA P130012S007
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- Product code
- DTB
- Decision date
- 2019-07-15
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- Modify the purchase of mesh raw material and addition of processing steps.
Current openFDA PMA Record#
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S007
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2019-07-15
- Decision code
- OK30
- Date received
- 2019-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the purchase of mesh raw material and addition of processing steps.