FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
PMA: P850051
·
Supplement: S064
·
Decision Dec 11, 2006
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Pulse-Generator, Single Chamber, Sensor Driven, Implantable
- Trade Name
- LEGACY SR IPG
- PMA Number
- P850051
- Supplement Number
- S064
- Device Class
- FDA Class 3
- Product Code
- LWO
- Generic Name
- Pulse-generator, single chamber, sensor driven, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 11, 2006
- Date Received
- November 20, 2006
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
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 |
|---|---|---|---|
| LWO | Pulse-Generator, Single Chamber, Sensor Driven, Implantable | FDA class 3 | Unknown |