FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Defibrillator, Implantable, Dual-Chamber
PMA: P050023
·
Supplement: S084
·
Decision Jul 17, 2015
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Defibrillator, Implantable, Dual-Chamber
- Trade Name
- COROX OTW 75-UP STEROID,COROX OTW 85 UP STEROID
- PMA Number
- P050023
- Supplement Number
- S084
- Device Class
- FDA Class 3
- Product Code
- MRM
- Generic Name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 17, 2015
- Date Received
- March 6, 2015
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR IMPLEMENTATION OF PARAMETRIC RELEASE IN PLACE OF CONVENTIONAL PRODUCT RELEASE IN THE STERILIZATION PROCESS FOR PERMANENT PACEMAKER AND DEFIBRILLATION LEADS.
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 |
|---|---|---|---|
| MRM | Defibrillator, Implantable, Dual-Chamber | FDA class 3 | Unknown |