Catheter, Percutaneous, Long Term, Intraspinal
Basic Information
- Device Name
- Catheter, Percutaneous, Long Term, Intraspinal
- Trade Name
- PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
- PMA Number
- P900052
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- LNY
- Generic Name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Medical Specialty
- Unknown
- Advisory Committee
- General Hospital
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 28, 2007
- Date Received
- December 8, 2006
- 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 A CHANGE TO THE IN-PROCESS MANUFACTURING PACKAGE INSPECTION PROCEDURE OF THE PORT-A-CATH EPIDURAL AND PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS. THE MODIFICATIONS TO THE IN-PROCESS POUCH SEAL INSPECTION INCLUDES: 1) FIVE TEST INTERVALS WILL BE PERFORMED OVER A SINGLE DAY VERSUS THREE TEST INTERVALS PER EACH MANUFACTURING JOB. 2) THE CURRENT FIVE POUCHES TESTED USING THE PULL TEST WILL BE REDUCED TO TWO POUCHES PER TEST PERIOD AND THE CURRENT TWO POUCHES INSPECTED USING HAND PEEL AND VISUAL VERIFICATION WILL BE INCREASED TO FIVE POUCHES PER TEST PERIOD. 3) THE RESULTS OF THE GAGE PULL TEST AND VISUAL INSPECTION WILL BE RECORDED IN THE INDIVIDUAL JOB FOLDER PER ESTABLISHED TEST INTERVAL. 4) THE POUCH SEALING PROCESS PARAMETER SETTINGS WILL CONTINUE TO BE RECORDED FOR EACH JOB AND EACH INSPECTION INTERVAL.
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 |
|---|---|---|---|
| LNY | Catheter, Percutaneous, Long Term, Intraspinal | FDA class 3 | Unknown |