PMA P910001S015
- Device
- EXTREME XTO .9 MM CORONARY ANGIOPLASTY CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S015
- Product code
- LPC
- Decision date
- 2000-07-11
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR THE EXTREME 0.9 MM CORONARY ANGIOPLASTY CATHETER.
Current openFDA PMA Record#
- Device
- EXTREME XTO .9 MM CORONARY ANGIOPLASTY CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S015
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2000-07-11
- Decision code
- APPR
- Date received
- 1999-03-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE EXTREME 0.9 MM CORONARY ANGIOPLASTY CATHETER.