FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Leadless Pacemaker
PMA: P150035
·
Supplement: S010
·
Decision May 1, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Leadless Pacemaker
- Trade Name
- Aveir VR Delivery Catheter and Aveir DR Delivery Catheter
- PMA Number
- P150035
- Supplement Number
- S010
- 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
- May 1, 2024
- Date Received
- April 3, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to update weld schedule, validated limits, process outputs for the ultrasonic welding of the Valve Bypass Tool (VBT), updates to the VBT subassembly and VBT Cap component print specifications
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 |