PMA P120017S033
- Device
- Myocardial Pacing Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P120017
- Supplement
- S033
- Product code
- DTB
- Decision date
- 2023-08-01
- Classification
- Cardiovascular
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- Modifications to the cutting and straining process for raw silicone material at a supplier.
Current openFDA PMA Record#
- Device
- Myocardial Pacing Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P120017
- Supplement
- S033
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2023-08-01
- Decision code
- OK30
- Date received
- 2023-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the cutting and straining process for raw silicone material at a supplier.