ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, DR MRI IPG, ENPULSE EL IPG, E2 IPG, ENRHYTHM IPG, KAPPA D IPG

FDA premarket approval P980035/S343 · decided 2014-02-14

Approval details

PMA number

P980035

Supplement

S343

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, DR MRI IPG, ENPULSE EL IPG, E2 IPG, ENRHYTHM IPG, KAPPA D IPG

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2013-08-23

Decision date

2014-02-14

Days to decision

175 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).

510(k) clearances by this applicant