PMA P880006S028

Device: REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S028
Product code: DXY
Decision date: 1998-10-15
Generic name: implantable pacemaker Pulse-generator
Approval order statement: The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.

Current openFDA PMA Record

Device: REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S028
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1998-10-15
Decision code: OK30
Date received: 1998-09-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.