PMA P970013S072
- Device
- Microny Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S072
- Product code
- LWO
- Decision date
- 2017-09-11
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- Change in the header manufacturing process.
Current openFDA PMA Record#
- Device
- Microny Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S072
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2017-09-11
- Decision code
- OK30
- Date received
- 2017-08-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the header manufacturing process.