PMA P200028S014
- Device
- DIAMOND AF
- Applicant
- Medtronic, Inc.
- PMA number
- P200028
- Supplement
- S014
- Product code
- OAE
- Decision date
- 2022-11-16
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval for changes to the protocol inclusion and exclusion criteria.
Current openFDA PMA Record#
- Device
- DIAMOND AF
- Applicant
- Medtronic, Inc.
- PMA number
- P200028
- Supplement
- S014
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2022-11-16
- Decision code
- APPR
- Date received
- 2022-10-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for changes to the protocol inclusion and exclusion criteria.