PMA P150023S006
- Device
- ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P150023
- Supplement
- S006
- Product code
- PNY
- Decision date
- 2016-11-22
- Classification
- Absorbable Coronary Drug-eluting Stent
- Generic name
- Absorbable coronary drug-eluting stent
- Approval order statement
- Add an alternate supplier of platinum marker beads and to automate the marker bead placement process.
Current openFDA PMA Record#
- Device
- ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P150023
- Supplement
- S006
- Product code
- PNY
- Generic name
- Absorbable coronary drug-eluting stent
- Decision date
- 2016-11-22
- Decision code
- OK30
- Date received
- 2016-10-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier of platinum marker beads and to automate the marker bead placement process.