SELECTSECURE LEAD
FDA premarket approval P030036/S009 · decided 2009-02-25
Approval details
- PMA number
- P030036
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELECTSECURE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-08-22
- Decision date
- 2009-02-25
- Days to decision
- 187 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES: 1) A CHANGE IN THE MANUFACTURING FACILITY FOR THE DRUG VIAL FILLING PROCESS; 2) THE ADDITION OF A CONTRACT LABORATORY FOR DRUG RELEASE TESTING; AND 3) A CHANGE IN A QUALITY CONTROL TEST USED TO DETERMINE A SPECIFIC ATTRIBUTE OF AN INCOMING RAW MATERIAL.
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