MEDTRONIC ATTAIN STARFIX

FDA premarket approval P060039/S003 · decided 2009-01-16

Approval details

PMA number

P060039

Supplement

S003

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC ATTAIN STARFIX

Generic name

Drug eluting permanent left ventricular (lv) pacemaker electrode

Applicant

Medtronic, Inc.

Date received

2008-07-21

Decision date

2009-01-16

Days to decision

179 days

Decision code

APPR

Product code

OJX

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR 1) USE OF NEW ANALYTICAL METHODS FOR ASSAY, CONTENT UNIFORMITY AND IDENTITY TESTING;2) TIGHTENING OF THE ASSAY SPECIFICATION RELATIVE TO THE LABEL CLAIM;3) MODIFICATION OF THE ELUTION SPECIFICATION WITH AN ADDITIONAL TIME POINT AND UPDATEDACCEPTANCE CRITERIA;4) MODIFICATION OF THE RESIDUAL SOLVENT SPECIFICATION;5) MODIFICATION OF THE APPEARANCE SPECIFICATION:6) USE OF A NEW LABORATORY FOR RELEASE AND STABILITY TESTING;7) USE OF NEW ASSAY, CONTENT UNIFORMITY, IDENTIFICATION, ELUTION

510(k) clearances by this applicant