OneStep Pacing Cable Assembly used wit R Series Device
FDA premarket approval P160022/S002 · decided 2018-05-29
Approval details
- PMA number
- P160022
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OneStep Pacing Cable Assembly used wit R Series Device
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2018-04-30
- Decision date
- 2018-05-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Change the manufacturing site location of its accessories supplier for the R Series device to another existing facility.
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