PMA P130012S003
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S003
- Product code
- DTB
- Decision date
- 2017-06-08
- Classification
- Permanent Pacemaker Electrode
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- Approval for the addition of a 100% in-line inspection for gel lumps in the body tubing of the Myopore lead.
Current openFDA PMA Record#
- Device
- Myopore Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S003
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2017-06-08
- Decision code
- APPR
- Date received
- 2017-05-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a 100% in-line inspection for gel lumps in the body tubing of the Myopore lead.