ConMed PadPro Multifunction Electrodes
FDA premarket approval P200004/S001 · decided 2022-06-16
Approval details
- PMA number
- P200004
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ConMed PadPro Multifunction Electrodes
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Conmed Corporation
- Date received
- 2022-05-19
- Decision date
- 2022-06-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Utica, NY
- Statement
- Change the test site for sterilization test samples and remove redundant post-sterile finished device testing.
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