PMA P960013S028
- Device
- SJM ACTIVE & PASSIVE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S028
- Product code
- NVZ
- Decision date
- 2009-11-19
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR A MINOR PROCESS CHANGE TO AN SJM VENDOR IN THE MANUFACTURE OF SJM ACTIVE AND PASSIVE LEADS.
Current openFDA PMA Record#
- Device
- SJM ACTIVE & PASSIVE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S028
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2009-11-19
- Decision code
- APPR
- Date received
- 2007-02-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MINOR PROCESS CHANGE TO AN SJM VENDOR IN THE MANUFACTURE OF SJM ACTIVE AND PASSIVE LEADS.