PMA P960030S004

Device: PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS
Applicant: ABBOTT MEDICAL
PMA number: P960030
Supplement: S004
Product code: DTB
Decision date: 1998-10-08
Classification: Permanent Pacemaker Electrode
Generic name: permanent pacemaker Electrode
Approval order 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.

Current openFDA PMA Record#

Device: PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS
Applicant: ABBOTT MEDICAL
PMA number: P960030
Supplement: S004
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 1998-10-08
Decision code: OK30
Date received: 1998-09-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.