PMA P150023S009
- Device
- Absorb GTi Bioresorbable Vascular Scaffold (BVS) System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P150023
- Supplement
- S009
- Product code
- PNY
- Decision date
- 2017-06-23
- Classification
- Absorbable Coronary Drug-eluting Stent
- Generic name
- Absorbable coronary drug-eluting stent
- Approval order statement
- Extend the retest period from 60 months to 96 months for everolimus repackaged in Configuration I.
Current openFDA PMA Record#
- Device
- Absorb GTi Bioresorbable Vascular Scaffold (BVS) System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P150023
- Supplement
- S009
- Product code
- PNY
- Generic name
- Absorbable coronary drug-eluting stent
- Decision date
- 2017-06-23
- Decision code
- OK30
- Date received
- 2017-05-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extend the retest period from 60 months to 96 months for everolimus repackaged in Configuration I.