PMA P130012S015
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S015
- Product code
- DTB
- Decision date
- 2023-12-13
- Classification
- Cardiovascular
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- approval to implement a manufacturing process and supplier change for the mesh component of the Myopore Sutureless Myocardial Pacing Lead
Current openFDA PMA Record#
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S015
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2023-12-13
- Decision code
- OK30
- Date received
- 2023-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to implement a manufacturing process and supplier change for the mesh component of the Myopore Sutureless Myocardial Pacing Lead