PMA P960013S014
- Device
- SDX PERMANENT PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S014
- Product code
- NVZ
- Decision date
- 2006-06-08
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR THE REDUCTION IN THE HUMIDITY OVEN CURE-TIME FOR SJM LEADS.
Current openFDA PMA Record#
- Device
- SDX PERMANENT PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S014
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2006-06-08
- Decision code
- APPR
- Date received
- 2005-10-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE REDUCTION IN THE HUMIDITY OVEN CURE-TIME FOR SJM LEADS.