PMA P820018S070

Device: REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS
Applicant: St. Jude Medical, Inc.
PMA number: P820018
Supplement: S070
Product code: LWP
Decision date: 1996-10-03
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: MODIFICATIONS TO THE LABELING TO INCLUDE INFORMATION REGARDING THE USE OF CELLULAR TELEPHONES WITH PATIENTS WEARING THESE DEVICES

Current openFDA PMA Record

Device: REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS
Applicant: St. Jude Medical, Inc.
PMA number: P820018
Supplement: S070
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1996-10-03
Decision code: APPR
Date received: 1996-08-05
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: MODIFICATIONS TO THE LABELING TO INCLUDE INFORMATION REGARDING THE USE OF CELLULAR TELEPHONES WITH PATIENTS WEARING THESE DEVICES