PMA P980035S831
- Device
- Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDR06, ADDRL1, ADSR03, ADVDD01, SED01, SES01, VEDR01); Adapta, Versa, Sensia
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S831
- Product code
- NVZ
- Decision date
- 2026-02-10
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- a new vapor degreasing solvent
Current openFDA PMA Record#
- Device
- Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDR06, ADDRL1, ADSR03, ADVDD01, SED01, SES01, VEDR01); Adapta, Versa, Sensia
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S831
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-02-10
- Decision code
- OK30
- Date received
- 2026-01-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new vapor degreasing solvent