PMA P150039S002

Device
Tryton Side Branch Stent
Applicant
Poseidon Medical, Inc.
PMA number
P150039
Supplement
S002
Product code
MAF
Decision date
2017-08-10
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
Replace the pouch sealer equipment and to modify the sealer process parameters.

Current openFDA PMA Record#

Device
Tryton Side Branch Stent
Applicant
Poseidon Medical, Inc.
PMA number
P150039
Supplement
S002
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2017-08-10
Decision code
OK30
Date received
2017-07-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replace the pouch sealer equipment and to modify the sealer process parameters.