SELECTSECURE 3830
FDA premarket approval P030036/S003 · decided 2008-10-21
Approval details
- PMA number
- P030036
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELECTSECURE 3830
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-02-26
- Decision date
- 2008-10-21
- Days to decision
- 603 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE TO THE 1 CC SYRINGE USED TO MANUALLY MEASURE APPLICATION WITH A MANUALLY OPERATED AUTOMATED DISPENSER AND TO MODIFY THE DIMENSIONS OF THE FILLING TUBE TO PREVENT OVER-FILL OF THE PRECISELY MEASURED STEROID SOLUTION WITHIN THE FILLING TUBE.
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