ANCHORING SLEEVE KIT, 5867AS, SELECTSECURE LEAD, 3830
FDA premarket approval P030036/S048 · decided 2012-10-15
Approval details
- PMA number
- P030036
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANCHORING SLEEVE KIT, 5867AS, SELECTSECURE LEAD, 3830
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-09-21
- Decision date
- 2012-10-15
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ALTERNATE SUPPLIERS FOR MOLDED COMPONENTS.
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