PMA P900056S019
- Device
- ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S019
- Product code
- MCX
- Decision date
- 1996-09-04
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL TO MARKET THE RAIL ROTAWIRE UNDER THE NAME EXTRASUPPORT ROTAWIRE
Current openFDA PMA Record#
- Device
- ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S019
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 1996-09-04
- Decision code
- APPR
- Date received
- 1996-07-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO MARKET THE RAIL ROTAWIRE UNDER THE NAME EXTRASUPPORT ROTAWIRE