PMA P160015S008
- Device
- ZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160015
- Supplement
- S008
- Product code
- MKJ
- Decision date
- 2020-12-30
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- new tin-to-wire machines used in the manufacture of electrode assemblies
Current openFDA PMA Record#
- Device
- ZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160015
- Supplement
- S008
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-12-30
- Decision code
- OK30
- Date received
- 2020-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- new tin-to-wire machines used in the manufacture of electrode assemblies