FDA.reportPublic FDA data

PMA P960030S003

Device
PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S003
Product code
DTB
Decision date
1998-10-15
Classification
Permanent Pacemaker Electrode
Generic name
permanent pacemaker Electrode
Approval order statement
The 30-day Notice requested approval for use of parametric release as ana lternate to the current use of biological indicators in the releae of sterilized products.

Current openFDA PMA Record#

Device
PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S003
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
1998-10-15
Decision code
OK30
Date received
1998-09-15
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 ana lternate to the current use of biological indicators in the releae of sterilized products.