FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Leadless Pacemaker
PMA: P150035
·
Supplement: S006
·
Decision Mar 6, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- Aveir Delivery Catheter
- PMA Number
- P150035
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- PNJ
- Generic Name
- Leadless pacemaker
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 6, 2024
- Date Received
- February 2, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
implementation of additional start-of-batch testing for tether screw bond tensile strength and an additional in-process inspection of tether screw insertion depth in manufacturing the Aveir VR Delivery Catheter tethers
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 |
|---|---|---|---|
| PNJ | Leadless Pacemaker | FDA class 3 | Cardiovascular |