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PMA P820076

Device
EFH-16; S 60-K; S 60-J; S 60-S
Applicant
Biotronik, Inc.
PMA number
P820076
Supplement
S027
Product code
LWP
Decision date
2019-02-12
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for the implementation of new biological indicators and reduction of incubation time for the bioindicators for the sterilization process, the use of sterilization process P02 as an alternate sterilization process for cables and adaptors, and parametric release for the sterilization processes.

Current openFDA PMA Record#

Device
EFH-16; S 60-K; S 60-J; S 60-S
Applicant
Biotronik, Inc.
PMA number
P820076
Supplement
S027
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2019-02-12
Decision code
APPR
Date received
2018-06-14
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the implementation of new biological indicators and reduction of incubation time for the bioindicators for the sterilization process, the use of sterilization process P02 as an alternate sterilization process for cables and adaptors, and parametric release for the sterilization processes.