PMA P130012S001
- Device
- MYOPORE SUTURELESS MYOCARDIAL PACING LEAD
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S001
- Product code
- DTB
- Decision date
- 2016-09-19
- Classification
- Permanent Pacemaker Electrode
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- Implementation of a new silicone mill.
Current openFDA PMA Record#
- Device
- MYOPORE SUTURELESS MYOCARDIAL PACING LEAD
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S001
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2016-09-19
- Decision code
- OK30
- Date received
- 2016-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new silicone mill.