PMA P900056S107
- Device
- ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S107
- Product code
- MCX
- Decision date
- 2012-03-23
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
Current openFDA PMA Record#
- Device
- ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S107
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2012-03-23
- Decision code
- APPR
- Date received
- 2011-06-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.