PMA P010012S102
- Device
- CONTAK RENEWAL RF PULSE GENERATORS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S102
- Product code
- LWP
- Decision date
- 2007-01-26
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT IRELAND, TIPPERARY, IRELAND.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL RF PULSE GENERATORS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S102
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2007-01-26
- Decision code
- APPR
- Date received
- 2005-12-23
- 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 GUIDANT IRELAND, TIPPERARY, IRELAND.