PMA P910001S094
- Device
- ELCA
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S094
- Product code
- LPC
- Decision date
- 2017-07-18
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for modifications to inspection practices for the primary packaging of the affected devices.
Current openFDA PMA Record#
- Device
- ELCA
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S094
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2017-07-18
- Decision code
- APPR
- Date received
- 2017-06-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for modifications to inspection practices for the primary packaging of the affected devices.