PMA P160022S002
- Device
- OneStep Pacing Cable Assembly used wit R Series Device
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S002
- Product code
- MKJ
- Decision date
- 2018-05-29
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Change the manufacturing site location of its accessories supplier for the R Series device to another existing facility.
Current openFDA PMA Record#
- Device
- OneStep Pacing Cable Assembly used wit R Series Device
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S002
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2018-05-29
- Decision code
- OK30
- Date received
- 2018-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the manufacturing site location of its accessories supplier for the R Series device to another existing facility.