PMA P910019S002
- Device
- IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
- Applicant
- Intensive Technology, Inc.
- PMA number
- P910019
- Supplement
- S002
- Product code
- MCX
- Decision date
- 1996-09-17
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE REAR SEAL ASSEMBLY OF THE TEC DRIVE COMPONENT OF THE TEC CORONARY ATHERECTOMY SYSTEM
Current openFDA PMA Record#
- Device
- IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
- Applicant
- Intensive Technology, Inc.
- PMA number
- P910019
- Supplement
- S002
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 1996-09-17
- Decision code
- APPR
- Date received
- 1996-08-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE REAR SEAL ASSEMBLY OF THE TEC DRIVE COMPONENT OF THE TEC CORONARY ATHERECTOMY SYSTEM