INSYNC CRT-P & INSYNC III CRT-P

FDA premarket approval P010015/S086 · decided 2011-03-22

Approval details

PMA number

P010015

Supplement

S086

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

INSYNC CRT-P & INSYNC III CRT-P

Generic name

Drug eluting permanent left ventricular (lv) pacemaker electrode

Applicant

Medtronic, Inc.

Date received

2010-05-17

Decision date

2011-03-22

Days to decision

309 days

Decision code

APPR

Product code

OJX

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024,

510(k) clearances by this applicant