ANCHORING SLEEVE KIT, SELECTSECURE LEAD
FDA premarket approval P030036/S052 · decided 2012-12-20
Approval details
- PMA number
- P030036
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANCHORING SLEEVE KIT, SELECTSECURE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-11-21
- Decision date
- 2012-12-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
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