PMA P110019S050
- Device
- XIENCE PRIME EVERLIMUS CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S050
- Product code
- NIQ
- Decision date
- 2013-12-19
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO EXTEND THE SHELF LIFE TO 36 MONTHS FOR THE RX PLATFORMS OF THE DEVICES.
Current openFDA PMA Record#
- Device
- XIENCE PRIME EVERLIMUS CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S050
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-12-19
- Decision code
- APPR
- Date received
- 2013-06-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO EXTEND THE SHELF LIFE TO 36 MONTHS FOR THE RX PLATFORMS OF THE DEVICES.