PMA P130012S006
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S006
- Product code
- DTB
- Decision date
- 2019-02-21
- Classification
- Permanent Pacemaker Electrode
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- Approval for revisions and enhancements to the content in the Myopore lead Instructions for Use.
Current openFDA PMA Record#
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S006
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2019-02-21
- Decision code
- APPR
- Date received
- 2019-01-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions and enhancements to the content in the Myopore lead Instructions for Use.