PMA P980037S092
- Device
- AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S092
- Product code
- MCX
- Decision date
- 2024-05-24
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- implementation of a change from a manual to automated label cutting process
Current openFDA PMA Record#
- Device
- AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set
- Applicant
- Boston Scientific Corp
- PMA number
- P980037
- Supplement
- S092
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2024-05-24
- Decision code
- OK30
- Date received
- 2024-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a change from a manual to automated label cutting process