MEDTRONIC MODEL 2490C CARELINK MONITORS
FDA premarket approval P890003/S174 · decided 2009-10-08
Approval details
- PMA number
- P890003
- Supplement
- S174
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODEL 2490C CARELINK MONITORS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2009-09-08
- Decision date
- 2009-10-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES TO TWO TESTS IN THE FINAL PRODUCT TEST SYSTEM.
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