PMA P970013S086
- Device
- Microny
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S086
- Product code
- LWO
- Decision date
- 2021-04-09
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- Adjust sample size for bacterial endotoxin testing.
Current openFDA PMA Record#
- Device
- Microny
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S086
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2021-04-09
- Decision code
- OK30
- Date received
- 2021-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust sample size for bacterial endotoxin testing.