Last synced on 29 August 2025 at 11:05 pm

GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
TELECTRONICS PACING SYSTEMS, INC.
Trade Name
GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
Generic Name
Implantable cardioverter defibrillator (non-CRT)
Decision Date
7/3/1997
Days to Decision
1091 days
Decision Code
APPR
FDA Decision
Approval

GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
TELECTRONICS PACING SYSTEMS, INC.
Trade Name
GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
Generic Name
Implantable cardioverter defibrillator (non-CRT)
Decision Date
7/3/1997
Days to Decision
1091 days
Decision Code
APPR
FDA Decision
Approval