FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Permanent Pacemaker Electrode
PMA: P120017
·
Supplement: S039
·
Decision Feb 20, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Permanent Pacemaker Electrode
- Trade Name
- Myocardial Pacing Lead
- PMA Number
- P120017
- Supplement Number
- S039
- Device Class
- FDA Class 3
- Product Code
- DTB
- Generic Name
- permanent pacemaker Electrode
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 20, 2026
- Date Received
- January 22, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an update to the part cleaning process at supplier
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | FDA class 3 | Cardiovascular |