PMA P900056S017
- Device
- ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S017
- Product code
- MCX
- Decision date
- 1996-09-27
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR REVISED PRODUCT LABELING
Current openFDA PMA Record#
- Device
- ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S017
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 1996-09-27
- Decision code
- APPR
- Date received
- 1996-04-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED PRODUCT LABELING