PMA P920015S287
- Device
- HV Splitter/Adaptor kit
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S287
- Product code
- NVY
- Decision date
- 2024-06-21
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- to transfer the receiving and inspection activities of the HV Splitter/Adaptor Kit to another facility
Current openFDA PMA Record#
- Device
- HV Splitter/Adaptor kit
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S287
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2024-06-21
- Decision code
- OK30
- Date received
- 2024-05-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to transfer the receiving and inspection activities of the HV Splitter/Adaptor Kit to another facility