CARELINK DDMA SOFTWARE AND CARELINK MONITOR
FDA premarket approval P890003/S191 · decided 2010-10-19
Approval details
- PMA number
- P890003
- Supplement
- S191
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARELINK DDMA SOFTWARE AND CARELINK MONITOR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-04-22
- Decision date
- 2010-10-19
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MEDTRONIC ENRHYTHM PULSE GENERATORS AND ENTRUST (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) PROGRAMMER APPLICATION SOFTWARE MODEL 9987 (VERSION 7.2), MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) (PART OF MODEL 2490G CARELINK MONITOR SYSTEM), FIRMWARE, AND THE POST STERILIZATION MANUFACTURING TEST SOFTWARE.
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