PMA P920015S286
- Device
- HV Splitter, Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S286
- Product code
- NVY
- Decision date
- 2024-04-16
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- to transfer extrusion operations for multiple CRM components from the Santa Rosa facility to the Danvers facility
Current openFDA PMA Record#
- Device
- HV Splitter, Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S286
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2024-04-16
- Decision code
- OK30
- Date received
- 2024-04-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to transfer extrusion operations for multiple CRM components from the Santa Rosa facility to the Danvers facility