PMA P830045S060

Device: PARAGON II AND PHOENIX PULSE GENERATORS
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S060
Product code: LWP
Decision date: 1998-10-15
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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: PARAGON II AND PHOENIX PULSE GENERATORS
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S060
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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.