Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
Basic Information
- Device Name
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
- Trade Name
- MEDTRONIC ATTAIN STARFIX
- PMA Number
- P060039
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- OJX
- Generic Name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 16, 2009
- Date Received
- July 21, 2008
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR 1) USE OF NEW ANALYTICAL METHODS FOR ASSAY, CONTENT UNIFORMITY AND IDENTITY TESTING;2) TIGHTENING OF THE ASSAY SPECIFICATION RELATIVE TO THE LABEL CLAIM;3) MODIFICATION OF THE ELUTION SPECIFICATION WITH AN ADDITIONAL TIME POINT AND UPDATEDACCEPTANCE CRITERIA;4) MODIFICATION OF THE RESIDUAL SOLVENT SPECIFICATION;5) MODIFICATION OF THE APPEARANCE SPECIFICATION:6) USE OF A NEW LABORATORY FOR RELEASE AND STABILITY TESTING;7) USE OF NEW ASSAY, CONTENT UNIFORMITY, IDENTIFICATION, ELUTION AND RELATED SUBSTANCEANALYTICAL TEST METHODS DEVELOPED AT THE NEW LABORATORY;8) USE OF THE APPROVED APPEARANCE/ DESCRIPTION AND RESIDUAL SOLVENTS TEST METHODS AT THE NEW LABORATORY;9) USE OF THE NEW LABORATORY STERILITY TEST METHOD; AND10) UPDATE OF THE MODEL 4195 LEAD SHELF LIFE TO 12 MONTHS AND AGREEMENT THAT DRUG STABILITY DATA AT 18 MONTHS ARE ACCEPTABLE.
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 |
|---|---|---|---|
| OJX | Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | FDA class 3 | Unknown |