PMA P130012S010
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S010
- Product code
- DTB
- Decision date
- 2022-12-12
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- Approval for a supplier site change and subsequent manufacturing process changes.
Current openFDA PMA Record#
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S010
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2022-12-12
- Decision code
- APPR
- Date received
- 2022-08-08
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a supplier site change and subsequent manufacturing process changes.