FDA.reportPublic FDA data

PMA P020024S063

Device
AMPLATZER Duct Occluder Family (ADO, ADOII, Piccolo)
Applicant
ABBOTT MEDICAL
PMA number
P020024
Supplement
S063
Product code
MAE
Decision date
2020-05-23
Generic name
OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Approval order statement
Add a new sterilization cycle at an approved sterilization facility including the implementation of a new final pack configuration and optimized shippers.

Current openFDA PMA Record#

Device
AMPLATZER Duct Occluder Family (ADO, ADOII, Piccolo)
Applicant
ABBOTT MEDICAL
PMA number
P020024
Supplement
S063
Product code
MAE
Generic name
OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Decision date
2020-05-23
Decision code
OK30
Date received
2020-04-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add a new sterilization cycle at an approved sterilization facility including the implementation of a new final pack configuration and optimized shippers.