EPICARDIAL PATCH LEADS
FDA premarket approval P900061/S113 · decided 2012-07-18
Approval details
- PMA number
- P900061
- Supplement
- S113
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPICARDIAL PATCH LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-03-26
- Decision date
- 2012-07-18
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL CHANGE IN SILICONE TUBING MATERIAL USED IN THE MANUFACTURING OF VARIOUS CARDIAC LEADS AS A RESULT OF DISCONTINUATION OF THE CURRENT MATERIAL BY AN OUTSIDE SUPPLIER.
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