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EFH-16; S 60-K; S 60-J; S 60-S

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
BIOTRONIK, INC.
Trade Name
DIPLOS MODEL 05 A & B
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
Decision Date
2/15/1984
Days to Decision
491 days
Decision Code
APWD
FDA Decision
Withdrawal after approval

EFH-16; S 60-K; S 60-J; S 60-S

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
BIOTRONIK, INC.
Trade Name
DIPLOS MODEL 05 A & B
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
Decision Date
2/15/1984
Days to Decision
491 days
Decision Code
APWD
FDA Decision
Withdrawal after approval