PMA P110019S051
- Device
- XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORNARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S051
- Product code
- NIQ
- Decision date
- 2013-08-27
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGE IN THE TEST EQUIPMENT USED FOR THE IDENTIFICATION AND ASSAY OF BUTYLATED HYDROXYTOLUENE (BHT).
Current openFDA PMA Record#
- Device
- XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORNARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S051
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-08-27
- Decision code
- OK30
- Date received
- 2013-07-29
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN THE TEST EQUIPMENT USED FOR THE IDENTIFICATION AND ASSAY OF BUTYLATED HYDROXYTOLUENE (BHT).