PMA P000009S134
- Device
- Intica Neo 7 DR-T DF-1 ProMRI, Intica Neo 5 DR-T DF-1 ProMRI
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S134
- Product code
- MRM
- Decision date
- 2026-10-13
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- a change to the rework process for the manufacturing of the housing for pulse generators and ICDS
Current openFDA PMA Record#
- Device
- Intica Neo 7 DR-T DF-1 ProMRI, Intica Neo 5 DR-T DF-1 ProMRI
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S134
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-10-13
- Decision code
- OK30
- Date received
- 2026-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the rework process for the manufacturing of the housing for pulse generators and ICDS