PMA P110019S005
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S005
- Product code
- NIQ
- Decision date
- 2011-12-30
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- AUTOMATION OF THE EXISTING BALLOON NECKING PROCESS, LEAVING THE CURRENT MANUAL PROCESS AS AN ALTERNATE.
Current openFDA PMA Record#
- Device
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S005
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-12-30
- Decision code
- OK30
- Date received
- 2011-12-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AUTOMATION OF THE EXISTING BALLOON NECKING PROCESS, LEAVING THE CURRENT MANUAL PROCESS AS AN ALTERNATE.