PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

FDA premarket approval P960030/S004 · decided 1998-10-08

Approval details

PMA number

P960030

Supplement

S004

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

Generic name

permanent pacemaker Electrode

Applicant

ABBOTT MEDICAL

Date received

1998-09-16

Decision date

1998-10-08

Days to decision

22 days

Decision code

OK30

Product code

DTB

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

The 30-day Notice requested that FDA review a change in material from ETR and MDX silicone rubber to liquid silicone rubber, and a change in the manufacturing process, from transfer molding to liquid injection molding, using an approved vendor. These changes apply to the fins, tines, and suture sleeve components of the Passive Plus(R) Endocardial Pacing Leads.

510(k) clearances by this applicant