PMA P950001S003

Device: SELUTE PICOTIP STEROID ELUTING LEAD
Applicant: Boston Scientific
PMA number: P950001
Supplement: S003
Product code: DTB
Decision date: 1998-04-08
Generic name: permanent pacemaker Electrode
Approval order statement: Approval for: a) Selute(R) Picotip(TM) Steroid Eluting, Endocardial Pacing Lead Model 4030, 4031, 4032, 4033, 4034, and 4035 which are indicated for chronic pacing and asensing of the ventricle when used with a compatible pulse generator, and b) the use of the Cosmed of Illinois facility as an alternate sterilization site.

Current openFDA PMA Record#

Device: SELUTE PICOTIP STEROID ELUTING LEAD
Applicant: Boston Scientific
PMA number: P950001
Supplement: S003
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 1998-04-08
Decision code: APPR
Date received: 1997-10-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for: a) Selute(R) Picotip(TM) Steroid Eluting, Endocardial Pacing Lead Model 4030, 4031, 4032, 4033, 4034, and 4035 which are indicated for chronic pacing and asensing of the ventricle when used with a compatible pulse generator, and b) the use of the Cosmed of Illinois facility as an alternate sterilization site.