PMA P240011
- Device
- Altaviva™
- Applicant
- Medtronic Neuromodulation
- Product code
- QPT
- Decision date
- 2026-08-14
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Approval order statement
- implementation of manufacturing controls for Intellis rechargeable lithium-ion batteries.
Current openFDA PMA Record#
- Device
- Altaviva™
- Applicant
- Medtronic Neuromodulation
- PMA number
- P240011
- Supplement
- S015
- Product code
- QPT
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Decision date
- 2026-08-14
- Decision code
- OK30
- Date received
- 2026-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of manufacturing controls for Intellis rechargeable lithium-ion batteries.